Orthosis apparatus and method of use

ABSTRACT

An improved orthosis apparatus for being selectively formed and applied and removed having offset zipper closures on two shell members for improved hinging and opening and access for initial application and forming when malleable and for removing and reinstalling when hardened.

RELATED APPLICATIONS

This non-provisional patent application claims priority pursuant to 35U.S.C. § 119(e) to and is entitled to the filing date of U.S.Provisional Patent Application Ser. No. 62/638,107 filed Mar. 3, 2018,and entitled “Orthosis Apparatus and Method of Use.” The contents of theaforementioned application are incorporated herein by reference.

BACKGROUND

The subject of this patent application relates generally to medicalimmobilization or orthotic devices, and more particularly to an orthosisapparatus configured for being selectively formed and applied andremoved.

The following description includes information that may be useful inunderstanding the present invention. It is not an admission that any ofthe information provided herein is prior art or relevant to thepresently claimed invention, or that any publication specifically orimplicitly referenced is prior art.

Applicant(s) hereby incorporate herein by reference any and all patentsand published patent applications cited or referred to in thisapplication, to the same extent as if each individual publication orpatent application were specifically and individually indicated to beincorporated by reference. Where a definition or use of a term in anincorporated reference is inconsistent or contrary to the definition ofthat term provided herein, the definition of that term provided hereinapplies and the definition of that term in the reference does not apply.

By way of background, immobilization of fractured or injured joints orlimbs typically involves the process of restraining the joint or limb inplace with a splint, cast, or brace. This is done to prevent thefractured/injured area from moving or being disturbed during the healingprocess.

Traditionally Plaster of Paris on fabric or gauze bandage has been usedto form casts for the immobilization of limbs. However, Plaster of Parishas a number of disadvantages associated with it. For example, Plasterof Paris is relatively heavy and bulky, has a slow setting time, cannotbe reformed once set, possesses low impact resistance, and issusceptible to deterioration or damage once exposed to moisture thusmaking bathing and showering difficult. Additional concerns associatedwith the use of Plaster of Paris casting bandages are that they requirea significant amount of time, usually 24 to 72 hours, to achieve theirmaximum strength, and that heat is generated from the exothermic settingreaction. Plaster of Paris also has poor radiopacity, which oftenprevents the continued monitoring of the limb during the healingprocess. In addition, Plaster of Paris is substantially impervious totransmission of water vapor, such as perspiration. Thus, Plaster ofParis traps moisture, which can result in significant skin maceration.

Similarly, more recently fiberglass casts have been introduced that aresimilar to Plaster of Paris casts in terms of being applied or wrappedon the affected limb over a sock or dressing of some kind but arerelatively lighter weight and stronger as being formed from wovenfiberglass typically coated with a polyurethane resin. Such fiberglassmaterial is also known to set faster, in on the order of 30 minutes to 2hours versus the 24 to 72 hours for Plaster of Paris casts. However,fiberglass casts are also not particularly breathable or waterproof and,like Plaster of Paris casts, cannot be reformed once set and so mustinstead be cut off in order to evaluate the limb or affected area and anew cast applied if further immobilization is deemed necessary by theclinician.

One partial solution to improve breathability is the use of athermoplastic mesh as disclosed in U.S. Pat. No. 4,143,655 to Custer etal. A drawback with this method, however, is the necessity to applymultiple layers of mesh to achieve adequate strength to support andprotect body areas. Another drawback of this method is that the meshneeds to be trimmed in order to fit different body areas and thisresults in sharp edges that are formed due to trimming. Anotherdisadvantage of this method is that underlying bandages, padding,dressings, and gauzes can become wet because the material is usuallyheated using a hot water bath to soften the material to facilitatemolding. Moist dressings promote bacteria growth and can lead todiscomfort and further complications.

Other proposed solutions involve the use of thermoplastic materials. Itis usually prescribed that thermoplastic mesh and thermoplastic sheetswith perforations are heated using a water bath (see, e.g., U.S. Pat.No. 6,093,161). This will help to reduce the (unwanted) high tackcharacteristic associated with these materials, which makes it otherwisedifficult for the user to handle. However, this means that these devicesand materials are often wet when applied which can again in someinstances sustain bacteria growth and MRSA or more generally just beunpleasant for the patient.

In the case of casts and splints it is important that such devices andmaterials also have sufficient strength to maintain correct alignment offractured bones, or to restrict movement of a limb in order to promotehealing, or to stabilize and help reduce swelling of injured limbs, orto protect a body area from impact and injury, or in some cases evensupport weight or be load-bearing. Specifically, in cases where devicesor materials are used to protect body parts from impact and injury it isimportant that the devices or materials have sufficient strength towithstand an impact and also be capable of transmitting/dissipating theforce of the impact onto and across underlying padding or shockabsorbing materials to reduce or prevent injury to the underlying bodypart on humans and animals.

Those skilled in the art will recognize the importance of havingbreathable and open surfaces in devices and materials used forimmobilization, bracing, casting, protection, or support of limbs andbody parts on humans and animals in order to reduce skin macerationproblems and clinical complications and to promote a reduction ofhealing times while still providing the aforementioned strength andworkability and convenience in use.

In the context of ankle and foot orthoses (“AFO”), as with other limbsthat may be treated, it is generally desirable to have a strong andlightweight, breathable cast or splint device that is relatively easy touse and form to the patient and thus to apply, preferably in a mannerthat allows for the removal and reapplication of the device rather thanhaving to destroy it and form another. This would be particularlybeneficial, for example, in the context of diabetic foot casting, agrowing market segment where casts typically have to be replaced on aweekly basis to change wound dressings, which could lead to up to 10 ormore casts per episode.

One of the main design challenges with AFO products and other orthoticsis accommodating the large variances in limb sizes across populations,since such orthotic devices are pre-formed and so typically are of arelatively fixed size. Taking again the AFO example, dimensions such asoverall foot length, ball of foot circumference, circumference at themalleoli, heel length to knee, and calf circumference all come intoplay, with other variations seen even on a single patient due toswelling increases or decreases over time. With a non-stretchable orsomewhat rigid device, this would require several sizes andconfigurations to cover the population (e.g., 95 percentile).

Previous approaches to such sizing challenges for the pre-formed cast,splint or brace product involve two halves or shells or a single pieceof formable material, either way with overlapping edges, which helps toreduce the number of sizes needed but results in having a product withexcessive material, thus extra cost. Furthermore, those overlappingedges may cause a crease and be uncomfortable on the patient. Indiabetic patients this can lead to ulceration of the underlying skin.One example of such a thermoformable product with overlapping edges isshown in U.S. Pat. No. 8,303,527 to Joseph (see, e.g., FIGS. 16, 21 and22). In the case of walker boots, a large amount of padding is oftenused and/or an air bladder to accommodate the general population, andyet this still results in at least 5 sizes being needed in knownapplications.

The use of zippers to selectively join opposed edges in orthopedicdevices rather than having such edges overlap is also generally known.For example, U.S. Pat. No. 6,093,161 to Vlaeyen et al. entitled“Thermoplastic Apparatus with Fastener” discloses a sheet ofthermoplastic material that is pre-cut in a shape that generallyconforms to and encircles a limb or other body part to be treated, withthe fastener such as a zipper directly attached to the opposing edges ofthe thermoplastic material to allow such to be selectively removed fromand put back on the treated area. However, such thermoplastic apparatusstill suffers from a number of shortcomings in use. For one, there isdifficulty in getting the apparatus on and off since there is only onezipper and otherwise there is no hinge region opposite the fastener toallow greater opening of the apparatus while still in its hardened orrigid condition, as it is undesirable to attempt to reheat such athermoplastic orthopedic device while being worn for a number ofreasons. Secondly, the Vlaeyen thermoplastic apparatus being pre-cut toa shape to encircle a particular area to be treated and being joinedalong a single non-overlapping edge while not being engineered orprovided with features enabling larger scale stretch or sizingadjustment of the apparatus when moldable, it suffers from the drawbacksof other known pre-formed orthopedic devices in terms of the number ofsizes of the device required to accommodate the large variances in limbsizes across populations.

What has been needed and heretofore unavailable is an orthosis apparatusconfigured for being selectively formed and applied and removed that isrelatively easy to use in custom molding or forming when malleable andin removing and reapplying when hardened and that is comfortable andbreathable when worn while providing the necessary structural supportand proper anatomical fit to the treated area, all while being costeffective as by eliminating excess material and reducing the totalnumber of sizes required to treat the majority of the target population.

Aspects of the present invention fulfill these needs and provide furtherrelated advantages as described in the following summary.

SUMMARY

Aspects of the present invention teach certain benefits in constructionand use which give rise to the exemplary advantages described below.

The present invention solves the problems described above by providingan improved orthosis apparatus for being selectively formed and appliedand removed. In at least one embodiment, offset zipper closures on twoshell members are provided for improved hinging and opening and accessfor initial application and forming when malleable and for removing andreinstalling when hardened.

According to a further aspect, the shell configuration (geometry andmaterial) is designed for structural integrity of the zipper closuresand of the overall apparatus while allowing for optimized stretch whenmalleable so as to reduce the number of sizes required to accommodatethe majority of the target population.

According to a still further aspect, a selectively removable or hingedtoe box is provided for protection of the toes and access to the toesfor inspection without removal of the apparatus.

According to a still further aspect, selective insertion of a moldableor non-moldable insole with or without an optional rocker is providedfor comfort and support and improved weight distribution in diabetictotal contact cast applications.

And according to a still further aspect, selective insertion and use ofan inflation bladder is provided to accommodate anatomical variancespost-forming (once the apparatus is formed and hardened) such as due toincreased or decreased swelling in the treated area.

And according to a still further aspect, selective insertion and use ofa cold therapy pad is provided to cool the underlying joint or skin toreduce swelling and pain and promote recovery of the treated areapost-forming (once the apparatus is formed and hardened).

Other objects, features, and advantages of aspects of the presentinvention will become more apparent from the following detaileddescription, taken in conjunction with the accompanying drawings, whichillustrate, by way of example, the principles of aspects of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate aspects of the present invention.In such drawings:

FIG. 1 is a perspective view of an exemplary orthosis apparatus, inaccordance with at least one embodiment;

FIG. 2 is a side elevation view of opposed body members thereof in apre-formed, unassembled state, in accordance with at least oneembodiment;

FIG. 3 is a side elevation view of opposed body members thereof in apre-formed, assembled state, in accordance with at least one embodiment;

FIG. 4 is a side elevation view of opposed body members thereof in apre-formed, assembled, folded state, in accordance with at least oneembodiment;

FIG. 5 is a perspective view thereof in an activated first operationalmode, in accordance with at least one embodiment;

FIG. 6 is a perspective view thereof in an activated second operationalmode, in accordance with at least one embodiment;

FIG. 7 is a perspective view thereof in a hardened third operationalmode, in accordance with at least one embodiment;

FIG. 8 is a perspective view thereof in a hardened fourth operationalmode, in accordance with at least one embodiment;

FIG. 9 is a perspective view thereof in a hardened fifth operationalmode, in accordance with at least one embodiment;

FIG. 10 is an exploded perspective view thereof, in accordance with atleast one embodiment;

FIG. 11 is an exploded perspective view thereof in an alternativeexemplary use, in accordance with at least one embodiment;

FIG. 12 is an exploded perspective view thereof in a further alternativeexemplary use, in accordance with at least one embodiment;

FIG. 13 is a perspective view of an alternative exemplary orthosisapparatus, in accordance with at least one embodiment;

FIG. 14 is a side elevation view of opposed body members thereof in apre-formed, unassembled state, in accordance with at least oneembodiment;

FIG. 15 is a side elevation view of opposed body members thereof in apre-formed, assembled state, in accordance with at least one embodiment;

FIG. 16 is a perspective view thereof in an activated first operationalmode, in accordance with at least one embodiment;

FIG. 17 is a perspective view thereof in an activated second operationalmode, in accordance with at least one embodiment;

FIG. 18A is a side elevation view thereof in a first exemplary hardenedthird operational mode, in accordance with at least one embodiment;

FIG. 18B is a side elevation view thereof in a second exemplary hardenedthird operational mode, in accordance with at least one embodiment;

FIG. 19 is a bottom perspective view thereof, in accordance with atleast one embodiment;

FIG. 20A is an enlarged, partial side elevation view thereof in thethird operational mode, in accordance with at least one embodiment;

FIG. 20B is an enlarged, partial side elevation view thereof in a fourthoperational mode, in accordance with at least one embodiment;

FIG. 21A is an enlarged sectional view taken from line 21A-21A in FIG.10, in accordance with at least one embodiment;

FIG. 21B is an enlarged sectional view taken from line 21B-21B in FIG.10, in accordance with at least one embodiment;

FIG. 21C is a further enlarged sectional view taken from line 21B-21B inFIG. 10, in accordance with at least one embodiment;

FIG. 22 is a perspective view of a further alternative exemplaryorthosis apparatus, in accordance with at least one embodiment;

FIG. 23 is a perspective, partially cut-away view of a still furtheralternative exemplary orthosis apparatus, in accordance with at leastone embodiment;

FIG. 24 is an exploded side elevation view of an alternative exemplaryinsole thereof in a pre-formed, unassembled state, in accordance with atleast one embodiment;

FIG. 25A is a side elevation view thereof in a formed, assembled state,in accordance with at least one embodiment;

FIG. 25B is a side elevation view a further alternative exemplary insolethereof in a formed, assembled state, in accordance with at least oneembodiment; and

FIG. 26 is a top elevation view a still further alternative exemplaryinsole thereof, in accordance with at least one embodiment.

The above described drawing figures illustrate aspects of the inventionin at least one of its exemplary embodiments, which are further definedin detail in the following description. Features, elements, and aspectsof the invention that are referenced by the same numerals in differentfigures represent the same, equivalent, or similar features, elements,or aspects, in accordance with one or more embodiments. More generally,those skilled in the art will appreciate that the drawings are schematicin nature and are not to be taken literally or to scale in terms ofmaterial configurations, sizes, thicknesses, and other attributes of anapparatus according to aspects of the present invention and itscomponents or features unless specifically set forth herein.

DETAILED DESCRIPTION

The following discussion provides many exemplary embodiments of theinventive subject matter. Although each embodiment represents a singlecombination of inventive elements, the inventive subject matter isconsidered to include all possible combinations of the disclosedelements. Thus, if one embodiment comprises elements A, B, and C, and asecond embodiment comprises elements B and D, then the inventive subjectmatter is also considered to include other remaining combinations of A,B, C, or D, even if not explicitly disclosed.

While the inventive subject matter is susceptible of variousmodifications and alternative embodiments, certain illustratedembodiments thereof are shown in the drawings and will be describedbelow in detail. It should be understood, however, that there is nointention to limit the invention to any specific form disclosed, but onthe contrary, the inventive subject matter is to cover allmodifications, alternative embodiments, and equivalents falling withinthe scope of any appended claims.

Generally and by way of introduction, the present specificationdiscloses an improved orthosis apparatus configured as an alternative tocasting and having benefits and advantages over traditional casts forpatients and clinicians. As plaster and fiberglass casts are made fromrolls of these materials and formed directly on the patient, sizing isnot an issue, at least as relating to any set dimensions, while such isan issue for pre-formed orthoses, though with other advantages. There isherein disclosed a somewhat symmetrically shaped two-half orthosisdevice with apertures and at least partially formed from re-moldablethermoplastic material that can be configured as a cast-type product forimmobilization, bracing, casting, splinting, protection, or support oflimbs and body parts on humans and animals. In the exemplary ankle andfoot orthosis (“AFO”) as shown, besides treating breaks, sprains andother injuries, a device according to aspects of the present inventionmay find application in treating such other diseases and conditions asdiabetic foot ulcers (“DFU's”), for which a so-called “total contactcast” (“TCC”) is often prescribed. The term “cast” employed hereingenerally refers to an embodiment of the device in one or more preformedsheets or shell portions used for limb immobilization, support, and/orprotection but is to be understood more broadly as any suchstabilization orthotic device in whatever form according to aspects ofthe present invention, and in any event all such illustrated embodimentsherein are to be understood as exemplary and non-limiting. Particularly,while the exemplary context is an AFO, it will be appreciated that adevice according to aspects of the present invention may findapplication in treating other injuries, diseases and conditions ofvarious human and animal limbs and other body parts, including but notlimited to the arm, wrist, and/or hand, the leg, the neck, and the backor torso.

Staying with the exemplary AFO context throughout for illustration,aspects of the orthosis apparatus relate to such a device configured forbeing selectively formed and applied and removed that is relatively easyto use in custom molding or forming when malleable and in removing andreapplying when hardened and that is comfortable and breathable whenworn while providing the necessary structural support and properanatomical fit to the treated area, all while being cost effective as byeliminating excess material and reducing the total number of sizesrequired to treat the majority of the target population. In regard tosizing, generally, it is expected that three sizes, nominally “small,”“medium,” and “large,” of such an orthosis apparatus with no overlappingedges may be provided employing features and aspects of the presentinvention as ensuring that an anatomically sufficient, customized fit isachieved in length and circumference across a substantial portion of thetarget (e.g., adult) population (e.g., 95% conformity), more about whichis said below in connection with FIGS. 1-3. For purposes ofillustration, the apparatus shown and described and any dimensionsdisclosed herein are in connection with the “medium” sized AFO, againwithout limitation, unless expressly indicated otherwise, as thoseskilled in the art will of course appreciate that the apparatus cansimply be scaled up or down in the AFO context, or scaled andreconfigured as needed for other contexts, without departing from thespirit and scope of the invention. At a high level, to overcome thedesign challenge of achieving anatomical conformity for the majority ofa target population with a minimal number of sizes of the orthosis, suchan apparatus has been devised with a particular geometry that isstretchable and/or compressible when in the pliable state to accommodatesizing. This is achieved by engineering the substrate in terms ofgeometry and material(s) to stretch in a certain range and/or direction.To assist in enabling the stretch function, one such exemplarythermoformable material and the means for its activation is as disclosedin commonly-owned U.S. Pat. No. 8,853,603 entitled “Thermo-FormableSupport Products and Heating Means Therefor,” incorporated herein byreference. Those skilled in the art will appreciate that all suchmaterial call-outs are illustrative of materials and properties that maybe employed in conjunction with and according to aspects of the presentinvention, but not necessarily and so are expressly to be understood asnon-limiting. By way of further illustration and not limitation, and asexplained further below, any such thermoformable substrate may be coatedon one or both sides or over its entire surface with a stretchablematerial (e.g., silicone with an elongation range). Furthermore, certainlateral areas of the apparatus are engineered not to stretch so as tomaintain a minimum strength and rigidity value so that the apparatuswill to some extent be load bearing in spite of other areas of thedevice being over-stretched on larger limbs and/or having relativelylarger apertures or relatively greater “openness” so as to reduce theoverall amount and weight of material and thus cost and improvebreathability. Once again, it will be appreciated that such designobjectives in various combinations and to various degrees may beaccomplished, in whole or in part, in a variety of orthosis devicesaccording to aspects of the present invention, such that the exemplaryembodiment is to be understood as illustrative and non-limiting.

Turning now to FIG. 1, there is shown a perspective view of an exemplaryembodiment of an orthosis apparatus 20 according to aspects of thepresent invention. The apparatus 20 comprises, in the exemplaryembodiment, opposed first and second shell members 30, 60 that areselectively joined along common or adjacent edges, here as by opposedfront and back zipper assemblies 90, 100, more about which is saidfurther below, particularly in connection with FIG. 3. It will beappreciated as a threshold matter that the apparatus 20 as shown in FIG.1 is in its formed and substantially rigid state after being molded orfitted to a patient, and thus in its malleable state being shaped andformed to substantially conform to such a patient's anatomy, again, herea lower leg, or ankle and foot area more particularly. In the detaileddiscussion below, there is described the method of forming suchapparatus 20 into the “in use” condition shown in FIG. 1. There is againformed in each shell member 30, 60 a plurality of variable-shapedapertures to provide the desired degree and direction of stretch and bythe same token improve breathability and weight-reductioncharacteristics of the apparatus 20. It will be appreciated that theattendant reduction in the total volume of material also translates tonot only reduced cost but also reduced heating time when activating theapparatus 20 for forming or fitment during use. In a bit more detail,with reference to both FIGS. 1 and 2, in the exemplary embodiment eachshell member 30, 60 is formed with at least three somewhat generallyidentifiable groups or regions of apertures: a leg or upper region ofapertures 42, 72; a foot or lower region of apertures 44, 74; and anintermediate region of apertures 46, 76. While particular shapes andsizes of such apertures are shown, those skilled in the art willappreciate that such is merely illustrative and non-limiting and that awide variety of shapes, sizes, and arrangements (locations,orientations, etc.) of such apertures is possible according to aspectsof the present invention. It is also noted that such nomenclature isused interchangeably to identify individual apertures within a region orthe region of apertures collectively. By way of further illustration andnot limitation, the one or more shells 30, 60 and specifically thesubstrates 36, 66 thereof and the related aperture regions 42, 44, 46,72, 74, 76 formed therein may be configured, in whole or in part, in anyconfiguration or manner now known or later developed, including but notlimited to any related disclosure in commonly owned U.S. Pat. No.7,985,192 entitled “Geometrically Apertured Protective and/or SplintDevice Comprising a Re-Mouldable Thermoplastic Material,” incorporatedherein by reference. Here, there is incorporated in each shell member30, 60 a so-called “high stretch zone” as the respective first andsecond upper aperture region 42, 72 due to relatively largediamond-shaped apertures formed basically in the calf area of therespective first and second shells 30, 60 of the apparatus 20 down tothe ankle. As will be appreciated, this provides a sizing solutionwherein a relatively greater degree of stretch, particularlycircumferentially, is made possible in the lower leg or calf area of thepatient, where relatively greater anatomical variation across thepopulation is typically seen, as will be further appreciated withreference to the below anatomic data presented in Table 2. Bycomparison, relatively smaller apertures 44, 46, 74, 76 are shown asbeing formed in the foot and ankle area of the apparatus 20, whererelatively less anatomical variance is typically seen, for increasedsupport and molding or shaping of the orthosis apparatus 20. Morespecifically, a further and different pattern or configuration ofapertures is shown in the first and second lower aperture regions 44, 74of the respective first and second shell members 30, 60, here shown aseither smaller diamond- or square-shaped openings in the substrates 36,66 and/or elongate somewhat rectangular openings. An optional first andsecond intermediate aperture region 46, 76 is further formed at theankle area, here shown as a somewhat radial pattern of aperturesconfigured and positioned to somewhat conform or correspond to themalleoli or ankle bone of the patient. Briefly, an optional toe boxmember 130 may be removably installed at the lower end 24 of theapparatus 20 to selectively cover and protect a patient's toes whileproviding selective access thereto, once again, more about which is saidfurther below, particularly in connection with FIGS. 6 and 10 inconnection with a first exemplary embodiment and with FIGS. 13, 17, and18 in connection with a second exemplary embodiment.

With continued reference particularly to FIG. 2, there are shown sideelevation or flat views of the first and second shell members 30, 60 intheir flat or pre-formed state, as after manufacture but prior to use oreven completed assembly of the exemplary orthosis apparatus 20. It willbe appreciated that the shell members 30, 60 may be molded or formedinto any desired shape, here again being substantially symmetrical,though such is not necessary, particularly in other contexts. In theillustrated AFO context, it will be further appreciated that by formingsuch shells 30, 60 effectively identically or as mirror images of oneanother, a single mold tool may be employed—of course, any appropriatemanufacturing method now known or later developed may be employedinstead of or in addition to such molding—and the resulting orthosisapparatus 20 having such symmetrical shells 30, 60 and being formableand customizable to the patient's anatomy may thus also be used oneither a left or right limb, further reducing the number of such unitsin terms of size or configuration that would preferably be kept on handor in stock. Those skilled in the art will note that the patterns ofapertures 42, 44, 46, 72, 74, 76 depicted here varies slightly fromthose of FIG. 1, which may be attributable to the stretch and distortionthe apertures may experience during shaping and forming for use of theapparatus 20 and is further representative of simply the variations suchapertures can take consistent with aspects of the present invention.Accordingly, it will again be appreciated that the drawings areschematic in nature and are not to be taken literally or to scale interms of material configurations, sizes, thicknesses, and otherattributes of an apparatus 20 according to aspects of the presentinvention and its components or features unless specifically set forthherein. In the context of such molded or otherwise formed flat “blanks”of the first and second shell members 30, 60, the respectivethermoformable substrate 36, 66 may be coated on one or both surfaceswith a respective coating 56, 86 (FIGS. 21A-21C) such as silicone,polyurethane (“PU”), or any other such stretchable material now known orlater developed. Those skilled in the art will appreciate that any suchcoating 56, 86 may be applied as by dipping (dip coating), spraying,over-molding, rolling, laminating, or any other such technique now knownor later developed in the art so as to bond to, coat with, or otherwiseinstall on the underlying substrate 36, 66 any such coating 56, 86.Relatedly, it will be appreciated that depending on the coating and theapplication technique, such may be on just one or both outwardly-facingside surfaces of the respective substrate or may completely cover thesubstrate, including the surfaces within the various apertures.Regardless, such coating would be applied as a relatively thin layer onthe order of 80 microns in thickness. It is noted that a coating such assilicone or the like may serve to prevent sticking and to enable robusthandling, heating, and application of the finished apparatus 20 in use.More particularly, those skilled in the art will appreciate that athermoformable material such as may be employed as the substrate of eachshell 30, 60 according to aspects of the present invention is typicallylike putty when heated and so would preferably have a material such asthe proposed coating(s) on one or both sides to help maintain theoverall shape and integrity of the shells 30, 60 even when heated andmalleable.

In terms of the properties of the one or more shells 30, 60 forming anorthosis apparatus 20 according to aspects of the present invention,taking for example such a shell configuration comprising athermoformable substrate 36, 66 such as made according to U.S. Pat. No.7,985,192 having a silicone coating applied thereover as by dip-coatingto a thickness of approximately 80 microns, the substrate itself havinga nominal thickness of 5 mm, exemplary mechanical properties of suchmaterials individually and collectively as an assembly as hereindescribed are set forth below in Table 1.

TABLE 1 Mechanical properties of thermoformable substrate and/or coatingmaterial Property Value Range Optimum Elasticity range of coatingmaterial 300% to 1300% 500% Modulus range of coating material @ 80° C.0.17 n/mm2 to 5.6 N/mm2 2.5 N/mm2 (force required to stretch a specifiedcross section in N/mm² by double (100% stretch)) Operating temperaturerange of coating −45° C. to 260° C. −5° C.-130° C. Thermal conductivityrange of coating 0.0005 w/mk to 0.2 w/mk 0.01 w/mk material Coatingmaterial thickness range (dry film) 40 μm to 200 μm 80 μm Modulus rangeof substrate material @ 80° C. 0.002 N/mm2 to 0.008 N/mm2 0.0029 N/mm2(force required to stretch a specified cross section in N/mm2 by double(100% stretch)) Modulus range of substrate and coating 0.003 N/mm2 to0.1 N/mm2 0.055 N/mm2 material together @ 80° C. (force required tostretch a specified cross section in N/mm2 by double (100% stretch))Activation temperature of the material/device 50° C. to 80° C. 70° C.(substrate and coating material together (e.g. 50° C. to 80° C.)

Referring still to FIGS. 1 and 2, and now with further reference to FIG.3, an exemplary orthosis apparatus 20 according to aspects of thepresent invention is shown still in its flat or pre-formed state, withthe respective first and second shell members 30, 60 now assembled asthrough the opposed front and back zipper assemblies 90, 100, thus hereonly the second shell member 60 being visible as being laid over on thefirst shell 30 from the orientation of FIG. 2, with the symmetricalsecond shell member 30 lying directly therebeneath in this view. Onceagain, one of the enablers of the improved functionality possibleaccording to aspects of the present invention is the deployment of twozipper assemblies 90, 100 in the AFO apparatus 20, which solves amultitude of issues. The zipper assemblies 90, 100 are attached to theopposed shells 30, 60, whether the substrates 36, 66 themselves or anycoating 56, 86 applied thereto (FIGS. 21A-21C). As a threshold matter,those skilled in the art will appreciate that while zippers areindicated as the means for fastening or selectively or temporarilyassembling the two shells 30, 60 along the respective adjacent edges 38,68, 40, 70, the invention is not so limited but may instead involve oremploy, in any manner or combination, any fastener device now known orlater developed, including but not limited to Velcro® hook-and-loopfasteners. Staying with the exemplary zipper fasteners, to enableselective opening and closing of the two shells 30, 60, the two zipperassemblies 90, 100 are attached to the shells 30, 60 to enable closurewhen applying on a patient and for opening of the apparatus 20 toprovide access to or to remove or inspect the limb, which is very usefulfor diabetic foot conditions, for example. In more detail, each zipperassembly 90, 100 is generally formed as is known in the art withengageable, opposed and alternating zipper teeth carried on oppositestrips 92, 94, 102, 104 that are then affixed typically along an edge ofwhatever substrate the zipper is to be installed and operate on. Here,with reference also to FIG. 1, the front zipper assembly 90 ispositioned at the front of the apparatus 20 or across the top of thefoot and up the front of the leg or shin and so has its first zipperstrip 92 attached along the first front edge 38 of the first shellmember 30 and has its second zipper strip 94 attached along the oppositesecond front edge 68 of the second shell member 60. Likewise, the backzipper assembly 100 is positioned at the back of the apparatus 20 oracross the bottom of the foot, around the heel, and up the back of theleg or calf and so has its first zipper strip 102 attached along thefirst back edge 40 of the first shell member 30 and has its secondzipper strip 104 attached along the opposite second back edge 70 of thesecond shell member 60. While zippers or other fasteners are shown asbeing under the foot and at the back of the leg and across the top ofthe foot and at the front of the leg, substantially opposite one anotheror roughly 180° apart, which has anatomical and use-related benefits asherein described, it will be appreciated that other locations andarrangements of such two or more zippers or the like may be employedaccording to aspects of the present invention without departing from itsspirit and scope, noting that other offset arrangements of such closureswould still provide the desired hinging and sufficient opening andaccess. As shown, each zipper assembly 90, 100 will have a zipper pull96, 98, 106, 108 at each end for sizing adjustment; thus, in theexemplary embodiment, the orthosis apparatus 20 has two zipperassemblies 90, 100 and four zip openers or zipper pulls 96, 98, 106,108, more about which is said below in connection with the apparatus 20in use. A variety of methods now known or later developed may beemployed in attaching the zipper assemblies 90, 100 to the respectiveshells 30, 60 as set forth herein, in part depending on the materials ofconstruction thereof. In that regard, the zipper strips 92, 94, 102, 104may be formed from any suitable somewhat flexible and inelastic ornon-stretchable material now known or later developed, including but notlimited to fabric or woven materials such as polyester or nylon orblends thereof, polyurethane (“PU”), or a silicone-coated textile, withthe material optionally coated with a PU, silicone, or other elastomericcoating or the like to waterproof and improve wear of the zipperassemblies 90, 100. Furthermore, the zipper pulls 96, 98, 106, 108, oneor more of which would be grasped during initial forming and fitment aswhen the product is heated and activated to be rendered malleable, andperhaps even the zipper teeth as well, which may also be contacted, canbe coated or insulated to prevent burns or uncomfortable hot sensationswhen being deployed, as again by silicone or PU or other insulationmaterial now known or later developed and suitable to such anapplication, particularly when such zipper components are made of metalor the like; to facilitate microwave heating of the apparatus 20, thezipper assemblies 90, 100 may contain no metal, but instead onlyplastics of various kinds. In one exemplary embodiment, the zipperassemblies 90, 100 are installed as by effectively bonding or embeddingthe respective zipper strips 92, 94, 102, 104 to or within any coatingmaterial 56, 86 applied to the shell substrates 36, 66 (FIGS. 21A-21C)when uncured. In a further exemplary embodiment, a two-sidedpressure-sensitive adhesive (“PSA”) tape 120 (FIG. 21C) may be employedbetween the respective zipper strips 92, 94, 102, 104 and the underlyingshell edges 38, 40, 68, 70, whether such shells 30, 60 or the substrates36, 66 thereof are coated or not. When a silicone coating is applied tothe shells 30, 60, such PSA tape 120 may be formed having an acrylic orrubber-based side facing the zipper strips 92, 94, 102, 104 and asilicone side facing the silicone-coated shells 30, 60. If a PUelastomer coated shell 30, 60 is used, a rubber-based or PU-based sideof the PSA tape 120 is affixed to the PU coated shell 30, 60 while theacrylic or rubber-based adhesive side is again facing the zipper strips92, 94, 102, 104. Or alternatively, in a still further alternativeexemplary embodiment, if a PU elastomer coated shell 30, 60 is used, aPU PSA tape 120 can be bonded to both the PU coated shell 30, 60 and thezipper strips 92, 94, 102, 104, as the PU PSA generally would stick toboth such surfaces. In still further embodiments, velour tape with anadhesive backing may be applied at both edges 38, 40, 68, 70 of therespective shells 30, 60, with the zipper strips 92, 94, 102, 104attached via a mushroom hook to the velour. Again, those skilled in theart will appreciate that any and all such attachment means now known orlater developed may be employed according to aspects of the presentinvention without departing from its spirit and scope. By way of furtherillustration and not limitation, double-sided tape in a variety offorms, stitching, in-tool over-molding, hot melt, hot laminating,solvent or other bonding, ultrasonic welding, and/or Velcro®hook-and-loop fasteners may be employed in operably securing the zipperassemblies 90, 100 on the shells 30, 60.

Dimensionally, once more, for purposes of illustration, the orthosisapparatus 20 shown and described is nominally a “medium” sized AFO, butthose skilled in the art will of appreciate that the apparatus 20 cansimply be scaled up or down in the AFO context or otherwise to suitother nominal size requirements or contexts without departing from thespirit and scope of the invention, such as will be appreciated from thebelow information relating to both “small” and “large” sized AFO devicesas well. But first, and staying with the AFO context for illustration,there are a number of anatomical factors relating to foot, ankle, andcalf size across the adult population that bear on the geometry of theexemplary AFO apparatus 20 according to aspects of the presentinvention. The biggest areas that vary in sizing are the calfcircumference relative to the circumference above the malleoli. (e.g.,skinny ankle and large calf). The circumference at the ball of the footis the next big variance, followed by the circumference over themalleoli heads. Representative, relevant anatomic dimensions are shownbelow in Table 2. As will be appreciated, there needs to be significantoverlap with the three proposed sizes of the orthosis apparatus 20 tocover roughly 95% of the target population. In practice, across thevarious sizes, to address the variances at all circumference regions,the various apertures 42, 44, 46, 72, 74, 76 are stretchable orcollapsible/compressible as the orthosis 20 is manipulated whilemalleable such that it effectively can grow or shrink in diameter or inoverall circumferential size at different locations along the length ofbody of the orthosis 20, particularly in the calf region where theapertures 42, 72 in the opposing shells 30, 60 are largest. In oneexemplary metric, the resulting circumferential stretch of the apparatus20 is up to 60%. Another way of expressing this attribute of such anorthosis apparatus 20 is its “openness,” or the effective surface areathat is open, or has an opening or perforation, as a percentage of theoverall surface area of the device. Such openness, which is of coursescalable or proportional across various sizes, is generally in the rangeof 20% to 45%, with the openness obviously being higher in the exemplaryembodiment in the upper or calf region associated with apertures 42, 72,lower in the lower or foot region associated with apertures 44, 74, andlikely lowest in the intermediate malleoli region associated withapertures 46, 76, though of course all such aspects being illustrative,and in any case the 20-45% range also being exemplary as an averageopenness across the entire orthosis apparatus 20. It will be furtherappreciated that such openness can vary not only as the product isscaled up or down in sizing but in use depending on the amount ofstretch; here, then, the openness range generally represents thevariance in openness across related AFO designs as both pre-formed(prior to use) and formed (during use).

TABLE 2 Indicative ankle, foot and calf anatomic dimensions (mm)Anatomic Dimensions Small Medium Large A Calf Circ 315 360 395 B AboveMalleo Circ 190 210 220 C Ball of Foot Circ 220 240 255 D Calf Height393 441 512 E Ankle Height (Lat) 60 60 65 F Foot Length 210 238 240 GHeel Breadth 50 55 60 H Above Malleo Height 110 120 130

As for representative dimensions of the exemplary AFO apparatus 20according to aspects of the present invention, reference is made to thebelow Table 3 showing nominal formed shell or substrate dimensions ascorrelating to the anatomic measurements of Table 2, whichcircumferential dimensions it is noted are for the overall orthosis 20,or both shells 30, 60 as coupled together and formed and hardened in useas shown, for example, in FIG. 1, rather than the dimensions for asingle shell. Again, in use, the circumferential dimensions may bevaried by up to 60% for extreme cases in accommodating variety acrossthe population. To address variance in leg length, it being observedherein that, while relatively significant circumferential stretch isachieved in the device by design (material and/or geometry), axial orlengthwise stretch of the orthosis apparatus 20 is limited particularlyin connection with the reinforced lengthwise edges 38, 40, 68, 70 of therespective shells 30, 60 where the zippers 90, 100 are attached, thethree sizes of the exemplary AFO device 20 were designed to the middleto high end of sizes across the population, which length can be adjusteddown as needed by trimming or folding back excess material at one orboth ends 32, 34, 62, 64 of the shells 30, 60, particularly the upperends 32, 34. At the lower ends 62, 64, where the anatomic dimension inquestion is foot length, the variance of which is to be accommodated byconfiguring the AFO device 20 in each size range to the average ormedian foot length for the target population, then providing theapparatus 20 with the optional toe box 130, more about which is saidbelow in connection with FIGS. 5 and 6 relating to the orthosisapparatus 20 in use. Where any trimming of the length of the apparatus20—of either or both of the shells 30, 60 is involved, it will beappreciated that such cannot interfere with or adversely affect theoperation of the closure system such as the opposing zipper assemblies90, 100, which though not shown may be affixed and configured in such away as to not extend to the marginal top and bottom shell edges to allowfor such trimming and folding. Or, product length can be adjusted at topand bottom by adjusting the zippers 90, 100 back (i.e., slightlyunzipping the zippers 90, 100 at one or both ends through the operationof the respective pulls 96, 98, 106, 108, with the material folded overthe ends of the product on to itself; in such case an optional “band” or“comfort cuff” may be used to provide a smoother edge. In the context ofthe “medium” sized orthosis apparatus 20 according to aspects of thepresent invention, and by way of further illustration and notlimitation, flat measurements such as of the shell 30, 60 in itspre-formed state as shown in FIG. 2 are an overall height ofapproximately 480 mm, an overall width of approximately 280 mm, a widthat the upper end 22 of approximately 170 mm, and a width at the lowerend 24 of approximately 110 mm. Staying with the exemplary “medium”sized orthosis, the effective inseam length along the selectivelyadjoining front edges 38, 68, which is essentially also the length ofthe upper zipper assembly 90, is approximately 490 mm, and the effectiveinseam length along the selectively adjoining back edges 40, 70, whichis also the length of that portion of the back zipper assembly 100attached to the shells 30, 60 at the back edges 40, 70, is approximately635 mm, with the overall length of the back zipper assembly being 790 mmlong, thus including a free portion of the back zipper assembly 100 thatextends beyond the lower ends 34, 64 of the shells 30, 60 to accommodateselective installation of the toe box 130 as herein described. Where anexemplary toe box 130 as shown in FIG. 1 is employed, in its flatcondition it may be approximately 100 mm wide by 140 mm long with itsedges chamfered or rounded, for example. Once again, those skilled inthe art will appreciate that all such dimensions are merely illustrativeof features and aspects of the present invention and non-limiting.

TABLE 3 AFO combined substrate dimensions (mm) Orthosis Dimensions SmallMedium Large A Calf Circ 298 343 378 B Above Malleo Circ 210 230 240 CBall of Foot Circ 203 223 238 D Calf Height 393 441 512 E Ankle Height(Lat) 65 65 70 F Foot Length 230 258 260 G Heel Breadth 60 65 70 H AboveMalleo Height 115 125 135

Briefly referring to FIG. 4, once the exemplary orthosis apparatus 20according to aspects of the present invention is assembled as shown anddescribed in connection with FIG. 3, with the apparatus 20 thus still inits flat or pre-formed state, as part of the manufacturing process, theapparatus 20 may be flash or locally heated at an intermediate locationso as to render such intermediate section formable, then bent at theformable section to effectively fold the product in half as shown,thereby reducing effectively by half the area or footprint required forthe product 20 in packaging/shipment/storage and for any microwave, dryheat oven, hot water bath or the like in which product 20 is heated inthe field to render it formable (i.e., to activate the product for use).One objective in particular exemplary embodiments is to render theorthosis apparatus 20 relatively small, or even as small as possible,while remaining fit for its function, thus enabling a smaller heatingsystem to be deployed (i.e. smaller foot-print, less energy consumption,faster heating time, etc.).

Turning next to FIGS. 5 and 6, there are shown perspective views of theexemplary AFO-type orthosis apparatus 20 according to aspects of thepresent invention in use. First, as seen in FIG. 5, with the apparatus20 heated to a forming temperature such as in the range of 50-80° C.,with further reference by way of illustration and not limitation againto U.S. Pat. Nos. 7,985,192 and 8,853,603, it is malleable and able tobe draped over the limb to begin the fitment process. As an overview,the limb or area to be treated, here a lower leg L (ankle and footarea), is prepped as by applying a sock S thereover as shown or anyother stocking, wrap, padding or the like as may be prescribed by theclinician. An optional inflation bladder 160 or cold therapy pad 170 mayalso be applied to the treatment site, more about which is said below inconnection with FIGS. 11 and 12. The orthosis apparatus 20 is thenheated employing any appropriate means, with the opposed flat shells 30,60 zipped or attached together as shown in FIG. 3 or even as providedfolded in half as shown in FIG. 4. Once activated, or heated andmalleable, the back zipper assembly 100 is opened typically at leasthalfway down, such as to the region of the heel to facilitate easyapplication onto the limb (typically while the patient is sitting orlying down facing the clinician), it being appreciated that leaving thelower portion of the back zipper assembly 100 zipped forms a nest orbottom area of the orthosis 20 against which the foot F and any optionalinsole 140 (FIG. 10) may be seated as the upper end 22 is pulledproximally to position the orthosis 20 as shown in FIG. 6 (as such, theback top zipper pull 106 is not visible in the FIG. 5 view. The frontzipper assembly 90 is shown as being substantially unzipped such thatthe front of the orthosis is effectively completely open, making itrelatively easy to slip the foot F in effectively from the back, or toslip the orthosis 20 onto the foot F and leg L from the front or top (orabove, once more, when the patient is seated facing the clinician withthe leg L elevated), thus both the top and bottom front zipper pulls 96,98 are shown as being positioned toward the upper end 22 of theapparatus 20, leaving just that end of the apparatus 20 connected inthis operational mode, with the two flexible or malleable shells 30, 60thus draped about the patient's leg L and foot F. An optional “doublesided hook” or other such device now known or later developed may beemployed to help maintain the AFO apparatus 20 upwards at this stage ifneeded. Again, with further reference to FIG. 10, if an optional insole140 is employed, it is placed between the bottom of the patient's foot Fand the bottom of the orthosis, more about which is said below but whichit will be appreciated serves at the very least to provide additionalpadding between the bottom of the foot F and the bottom portion of theback zipper assembly 100. Alternatively, any such insole 140 may beaffixed to the patient's sock S or other stocking or wrap in a mannerknown in the art. As shown, the insole 140 is substantially flat andfoot-shaped having an upwardly-facing surface 142 that is to be orientedtoward the foot F of the patient and an opposite downwardly-facingsurface 144 that in use would be oriented toward the bottom of theorthosis 20 or against a portion or lower end section of the back zipperassembly 100 for comfort; as such, it will be appreciated that theinsole 140 may be monolithic or formed from a single material throughoutor may formed in layers or otherwise from two or more materials, suchthat the opposed upwardly-facing and downwardly-facing surfaces 142, 144may not be the same material or construction, as will be furtherappreciated from the alternative exemplary insoles 140 shown anddescribed below in connection with particularly FIGS. 24 and 25.Furthermore, though the insole 140 is shown as being flat and of aparticular thickness, it will be appreciated that it may be thicker orthinner as desired and may be pre-formed with a prescribed shape, suchas having an arch support area or heel well, or such topographicalsurface features may be formed in the insole 140 in use as hereindescribed, such that the substantially flat configuration of the insole140 as shown in FIG. 10 is to be understood as merely illustrative andnon-limiting. If the insole 140 or the optional toe box 130 are made ofa thermoformable material also, such would be heated along with theorthosis apparatus 20 to render them malleable as well prior toplacement for optimum anatomical conformity. With the apparatus 20 andany optional accessories so positioned, the back zipper assembly 100 issubstantially closed as by pulling the back top zipper pull 106 (FIG. 1)upwardly toward the upper end 22 of the orthosis 20. This causes stretchzones as formed by the apertures, particularly the upper apertures 42,72, to stretch to allow the zipper 100 to fully close. Again, bothzipper pulls 106, 108 at both ends can be adjusted back, or unzippedslightly, to allow folding of the ends 22, 24 to provide a comfort edgearound the toes T and leg L as by setting the correct length below theknee. A wet wrap is then applied to cool and conform the AFO apparatus20 as the apparatus 20 continues to be shaped by the clinician along andabout the patient's leg L and foot F. To further aid in fitment, thepatient may stand, applying slight pressure so as to ensure that thefoot angle and position of the orthosis apparatus 20 is in the mostcomfortable position for the patient before it hardens and sets. Oncehardened, the wet wrap is removed. Where a flexible toe box 130 is to beemployed for selectively covering and protecting the toes T, such may beattached using Velcro® or any other removable engagement means now knownor later developed to both the free end of the back zipper assembly 100and to the top of the lower end 24 of the orthosis 20—in the exemplaryembodiment as shown, first and second zipper strip fastener members 112,114 are formed on the inside or upwardly facing surface of the free endof the back zipper 100 and similarly first and second shell fastenermembers 48, 78 may be formed or applied on the upwardly-facing lower endportion of the orthosis 20, one on each of the first and second shells30, 60. It will be appreciated that the toe box 130 may itself be ahook-and-loop material, or have such swatches formed, on its inner andouter surfaces 132, 134 capable of selectively engaging both the zipperswatches 112, 114 and the orthosis swatches 48, 78 so that the toe box130 may be selectively folded up and over the otherwise open lower end24 of the orthosis 20 and held in position as shown in FIG. 1. It willbe appreciated that in use such toe box 130 not only protects the toeregion T but selectively provides access thereto by simply disengagingor detaching the toe box 130 and/or zipper 100 from the top of theorthosis 20, with any sock S or stocking perhaps not being present atall or at least also being open-toed so as to allow the clinician toinspect the toes for good circulation or other indicia of health withoutremoval of the orthosis 20, which is particularly handy in cases where asecurity strap is employed. Optional straps may be applied foradditional strength and security, as by wrapping about the orthosis 20to prevent tampering or unauthorized removal. As to such security, acompliance strap such as disclosed in applicant's U.S. Pat. No.8,821,423, incorporated herein by reference, may be employed, which is atextile and Velcro® based strap. Alternatively, such a compliance strapmay also be formed of a thermoformable material, heated to be renderedmalleable along with the orthosis 20 and any other thermoformablecomponents, placed around the cast and attached to itself, and thencooled to lock or form an integral ring about the orthosis 20 that canonly be removed by destruction (e.g., cutting it off)—due to anysilicone or other such coating on the shells 30, 60, the thermoformablecompliance strap does not stick to the orthosis 20. If an inflationbladder 160 was fitted, it may be inflated/deflated to provide comfortand adjustment for swelling, more about which is again said below withreference to FIG. 11. To remove the exemplary AFO apparatus 20 as toevaluate the treated area or limb or administer therapy, for example, aclinician would simply unzip both zippers 90, 100 and remove the shells30, 60, and to then refit or install the AFO 20, the shells 30, 60 areplaced back in position and zipped back up. More specifically, to removethe device 20, the front zipper assembly 90 is fully opened and the backzipper 100 is opened downwards to the heel such that the two opposedshells 30, 60 may now hinge open to allow for easy insertion and removalof the limb while remaining connected as a single device 20 for easyrefitting later.

Briefly, FIGS. 7-9 show the exemplary orthosis apparatus 20 according toaspects of the present invention in various other illustrativeoperational modes that are self-explanatory in light of the presentspecification.

In terms of the indications for use, once more, there is provided in theexemplary embodiment an ankle and foot device 20 generally for thepost-operative & post-swelling treatment of ankle and foot fractures andother musculoskeletal injuries or conditions during the non-weightbearing and weight-bearing stages of healing. A standard cast shoe or asuitable walker boot can be fitted to the device 20 for weight bearing.The device 20 can be used to also treat fractures and other injuries ordiabetic foot ulcers as a total contact cast as by employing theseparate thermoformable insole 140 or the non-thermoformable insole 140with attachable rocker 154 (though appreciating that in some embodimentsthe rocker 154 may be employed with an insole 140 that isthermoformable, in whole or in part). In one or more aspects, anorthosis apparatus 20 according to the invention is custom moldable,breathable, and removable/replaceable while having anatomical conformityat least equivalent to or better than below-the-knee fiberglass castsand able to meet or exceed the average strength of a weight-bearingfiberglass cast and/or walker boot. Comfort being an important factorfor foot and ankle treatment because partial load is often exerted andcomplications can easily arise due to uncomfortable fitting casts, onceagain particularly in the context of diabetic foot ulcers. Furthermore,an orthosis apparatus 20 according to aspects of the present inventionis relatively easy to use, requiring few steps to activate and apply inminimal time (including heating/activation time) and to remove andreapply as needed, with no cast saw needed at any stage. There is alsothe attendant benefit of reduced cost, both in initial fabrication byremoving excess material, as by selectively placed stretch voids andhaving non-overlapping edges, and in that the device 20 is reusable, orable to be removed and reinstalled without being destroyed. It shouldalso be noted, though not shown, that the orthosis 20 once formed mayhave a stretchable and breathable fabric cover attached or otherwisepositioned on or over or within the orthosis 20. Such fabric may beLycra™ elastic polyurethane fiber or fabric or any other such materialnow known or later developed. It will be appreciated that such a coverwould help prevent dirt and debris from entering the orthosis 20 throughany of the apertures therein, which may be particularly beneficial againin the DFU context where the patient may have lost some or all of thefeeling in their feet and so may not feel such irritations caused bysand, gravel, and the like that could lead to a new ulcer site.

Such components and attributes of the exemplary orthosis apparatus 20according to aspects of the present invention in construction and use asdescribed herein are further shown in the exploded perspective view ofFIG. 10. Generally shown once more are the two halves or shells 30, 60of the apparatus 20 that are once more here configured to besubstantially symmetrical. The front and back zipper assemblies 90, 100are shown as separated for purposes of illustration, which may indeed bepossible if the respective pulls 96, 98, 106, 108 could be zipped orslipped off at one end or the other. Though not shown, in anotherembodiment, and as is also known in the art, such zipper assemblies 90,100 may be configured with zipper stops on one or both ends thereof toprevent the respective pulls 96, 98, 106, 108 from ever becomingdisengaged from the zippers, which it will be appreciated would meanthat at such a zipper end, the opposite edges of the respective shells30, 60 could not be separated, as might be the case, for example for theupper end of the front zipper assembly 90 and the lower end of the backzipper assembly 100 as best shown in FIG. 5, versus the upper end of theback zipper assembly 100 and the lower end of the front zipper assembly90 that are shown as being separated so as to temporarily allow a wideropening of the two shells 30, 60. Again, those skilled in the art willappreciate that other zipper configurations and other fastening meansaltogether, now known or later developed, may instead be employed in anorthosis apparatus 20 according to aspects of the present inventionwithout departing from its spirit and scope. With continued reference toFIG. 10 and also to FIGS. 1 and 6, the exemplary toe box 130 is oncemore potentially formed as relatively heavy and wide hook material onboth sides to have its lower or outer surface 134 attach to the hookfastener strips 112, 114 formed on the back side of the back zipperassembly 100 at is lower end and formed on the upper or inner surface132 to attach to hook fasteners 48, 78 formed on the upper surface ofthe lower end 24 of the orthosis 20, or at the lower ends 34, 64 of therespective shells 30, 60. Alternatively, the toe box 130 could be athermoformable material to which Velcro® swatches are affixed, such athermoformable toe box being shaped as explained herein, and as furtherappreciated with respect to the alternative exemplary embodiment ofFIGS. 13-22. Either way, it will be appreciated that in the exemplaryembodiment, the extended zipper 100 on the lower end 24 of the AFO 20facilitates attachment of the toe box 130 so that the zipper 100 isneatly anchored on the top side of the foot, which has severaladvantages in that the zipper would be uncomfortable if left on the soleof the foot, the zipper thereby assists in anchoring the toe box inposition to protect the toes, and the zipper extension, alone or incombination with the toe box, facilitates the accommodation of differentfoot lengths and removes the need for trimming, which would make thezipper configuration relatively complex to allow for different footlengths if trimmed also. For a total contact cast (“TOO”) for diabeticfoot ulcer treatment, the toe box 130 may again be made from athermoformable substrate or other such material for increaseddurability, protection, and compliance, again, as will be furtherappreciated from the alternative exemplary embodiments disclosed herein.

Referring next to FIG. 11, there is shown an exploded perspective viewof a further exemplary orthosis apparatus 20 according to aspects of thepresent invention, again comprising opposite shells 30, 60 and here, asin FIG. 10, a toe box 130 and insole 140. Regarding the insole 140, suchcould be sized and configured to suit a range of standard adult feet(e.g., 95 percentile) and made of any appropriate padding material nowknown or later developed to space the patient's foot from the bottom ofthe orthosis 20, and particularly the lower zipper assembly 100.Alternatively, such an insole 140 as shown in FIGS. 10 and 11 may alsobe formed from a thermoformable material so as to allow molding andanatomic conformance with the foot, rendering the insole 140 and thebase of the AFO apparatus 20 more generally a good fit and comfortable.By way of still further illustration and not limitation, the insole 140could be made from a compressible material (e.g., foam or foam-like), anopen cell foam or spacer fabric impregnated with a suitablethermoformable material, or any other such material that can be moldedwith the AFO apparatus 20 to take the shape of the foot and arches sothat when cool it distributes the weight across the foot because theskin of the foot is in contact with the complete surface of the insole140—pressure is distributed over the area of the foot—which isparticularly useful for pressure distribution and pressure offloading ofdiabetic ulcers. In yet a further exemplary embodiment, the toe box 130and the insole 140 may be formed Integrally as a single componentinserted within the orthosis 20 and protruding out of the lower end 24to wrap up and over the toes in use, again such unitary component beingpotentially formed of a thermoformable material or any other appropriatematerial now known or later developed. Relatedly, the toe box 130 may beformed so as to key or mate with the lower end 24 of the AFO apparatus20, with it and the AFO 20 both being formed of moldable, thermoformablematerial to form an integrated and more rigid toe box 130. In such anembodiment, and by way of further example, there may be integrated aresistance wire into the toe box 130 perimeter so that the toe box 130may be removed by connecting the wire to a 24 V DC or other such supply,which heats the wire and cuts through or softens the thermoformable orother material to allow removal of the toe box 130 in the alternativeexemplary embodiment. With continued reference to FIG. 11, there isfurther shown an inflation bladder 160 positioned within or between theshells 30, 60. In practice, such bladder 160 shown as beingsubstantially rectangular and flat, would be wrapped around the treatedlimb such as the leg L (FIG. 5) and positioned and secured where desiredprior to placement of the orthosis 20 as herein described. The inflationline 164 leading from and in fluid communication with the body 162 ofthe bladder 160 would be of sufficient length and flexibility so as tobe directed through one of the apertures in a shell of the orthosis 20,here illustrated as an upper aperture 42 in the first shell 30, and thenfed or laid along the shell 30 when not in use and secured in anysuitable manner now known or later developed. The free end of theinflation line 164 is shown as being configured with an inflation port166 such as a one-way valve for selectively inflating or deflating thebladder 160 in use as by connecting the inflation line 164 to a vacuumor pressure source or regulated air supply, hand pump, or the like toselectively administer or allow the escape of air to set the desiredpressure within the body 162 and thereby provide additional padding orincrease or decrease the volume within the orthosis 20 for the affectedlimb such as to account for decreased or increased swelling withouthaving to heat and in any way reform the orthosis apparatus 20. For themedium sized AFO 20 having dimensions as set forth herein, such abladder 160, and specifically the body 162 thereof, may be approximately300 mm wide by 150 mm high again with chamfered or radiused corners(e.g., radius of 20 mm). Once again, those skilled in the art willappreciate that such an orthosis apparatus 20 according to aspects ofthe present invention and related accessories can take a variety ofother forms without departing from the spirit and scope of theinvention, such that those shown and described are to be understood asmerely illustrative and non-limiting.

Similarly, with reference to FIG. 12, there is shown an explodedperspective view of a further exemplary use of an orthosis apparatus 20according to aspects of the present invention, such orthosis 20 againcomprising opposite shells 30, 60 and here, as in FIGS. 10 and 11, a toebox 130 and insole 140. Here, rather than employing an inflation bladder160 as shown in FIG. 11, a cold therapy pad 170 or other such treatmentdevice may be selectively inserted and used in conjunction with theorthosis apparatus 20, here, to cool the underlying joint (skin) so asto reduce swelling and pain and promote recovery post-forming (once theapparatus is formed and hardened) in and around the treatment area, suchas due to increased or decreased swelling and other physiologicalindications. The inlet and outlet lines 174, 178 of the cold therapy pad170 as protruding from and in communication with the body 172 thereofare once again conveniently accommodated through the many apertures indevice 20, here once more as extending through select one(s) of theupper aperture(s) 42 in the first shell 30, and then fed or laid alongthe shell 30 when not in use and secured in any suitable manner nowknown or later developed. The free ends of the inlet and outlet lines174, 178 may be configured with any appropriate inlet and outletconnector 176, 180 for operable connection to any cold therapy device tocirculate chilled coolant such as water through channels within the coldtherapy pad body 172 to provide even cooling across the underlyingjoint/skin. Though only the inflation bladder 160 is shown in use inFIG. 11 and only the cold therapy pad 170 in use in FIG. 12, it will beappreciated that both may be used simultaneously depending on a numberof factors, it being further appreciated that the openness of the device20 can accommodate various numbers and kinds of devices and therapies,such that the exemplary uses are to be understood as illustrative andnon-limiting. Furthermore, combining the features and functionality ofsuch accessories, the cold therapy pad 170 may also be used (dualpurpose) as an inflation bladder to accommodate anatomical variancespost-forming as described above in connection with the stand-aloneinflation bladder 160 of FIG. 11. When used as a cold therapy pad thepressure can be regulated to provide light pressure on the underlyingjoint/skin to ensure the AFO 20 fits snugly. And when the cold therapypad 170 is disconnected from the cold therapy cooling device (notshown), valves on the inlet and outlet lines 174, 178 of the coldtherapy pad 170 as incorporated into the respective connectors 176, 180enable the cold therapy pad 170 to be inflated with air to provide lightpressure on the underlying joint/skin to ensure continued anatomicalconformity of the AFO apparatus 20. Once more, it will be appreciatedthat such an orthosis apparatus 20 according to aspects of the presentinvention and related accessories can take a variety of other formswithout departing from the spirit and scope of the invention, such thatthose shown and described are to be understood as merely illustrativeand non-limiting.

Turning now to FIG. 13, there is shown a perspective view analogous tothat of FIG. 1, here of an alternative exemplary embodiment of anorthosis apparatus 20 according to aspects of the present invention. Theapparatus 20 once again comprises opposed first and second shell members30, 60 that are selectively joined along common or adjacent edges byopposed front and back zipper assemblies 90, 100, as described above,particularly in connection with FIGS. 3 and 5. Most notably, here,rather than the toe box 130 being a solid or single, somewhatrectangular piece of material that is removably engaged with the free ordistally-extending lower end of the bottom or back zipper assembly 100,and specifically its opposite first and second Velcro®-type zipper stripfastener members 112, 114 affixed on the respective first and secondzipper strips 102, 104 (FIG. 6), the toe box 130 is instead formed oftwo opposed sections or members 136, 138 that are affixed to orintegrated on or with the respective first and second zipper strips 102,104 to together form the toe box 130. In a bit more detail, thealternative exemplary toe box 130 is shown as comprising opposite firstand second toe box members 136, 138 that extend somewhat laterally awayfrom the back zipper assembly 100, again, as by being joined with therespective first and second zipper strips 102, 104, the means of whichmay include any joining or assembling technique now known or laterdeveloped in the art, including but not limited to double-sided tape ina variety of forms, stitching, in-tool over-molding, hot melt, hotlaminating, solvent or other bonding, ultrasonic welding, and/or Velcro®hook-and-loop fasteners. As best seen in FIGS. 15 and 16, discussedbelow, the first and second toe box members 136, 138 may be initiallyfabricated as somewhat flat strips of material that are then formed intothe desired shape subsequently. Indeed, the exemplary toe box 130, andspecifically its first and second toe box members 136, 138, are heremade of a thermoformable material as are the first and second shellmembers 30, 60 of the apparatus 20 itself, such that the toe box members136, 138 would then be heated along with the orthosis apparatus 20 torender them malleable as well prior to placement for optimum shaping ormolding and anatomical conformity, more about which is said below,particularly in connection with FIGS. 18A and 18B and the sizingcapabilities of such an alternative exemplary toe box 130 and thus ofthe overall apparatus 20. Those skilled in the art will appreciate thatby forming such a toe box 130 of thermoformable material that can notonly be shaped for a proper anatomical fit but then once set or hardenedwill provide further structural integrity for the overall orthosisapparatus 20 and somewhat rigid protection of the patient's toes,another area of vulnerability particularly for diabetic patients thathave lost some or all feeling in one or more toes that are thussusceptible to even unknown and untreated injury, there is thus providedan effective further alternative at the lower end 24 of the orthotic 20.With continued reference to FIG. 13, to facilitate forming the toe box130 as by curving and bending the opposite first and second toe boxmembers 136, 138 to the desired shape, the lateral edges of thosemembers 136, 138, or the lengthwise edges opposite where each is joinedor affixed on the respective first and second zipper strips 102, 104,may be formed with respective first and second protrusions 137, 139(FIG. 15 as to second protrusions 139) extending substantially laterallyaway from the respective first and second zipper strips 102, 104. Itwill be appreciated that such “teeth” or protrusions 137, 139 and thusthe space between them allows for the bending and curving of the toe boxmembers 136, 138 while minimizing or eliminating bunching of excessmaterial in the bends, as shown. While a particular size and shape andthus number of such protrusions 137, 139 are shown in the exemplaryembodiment, those skilled in the art will appreciate that such may varywidely depending on a number of factors, such that once again it shouldbe understood that the drawings are schematic in nature and not to betaken literally or to scale and, more generally, that all such exemplaryembodiments are illustrative of features and aspects of the presentinvention but expressly non-limiting. By way of further illustration andnot limitation, the protrusions 137, 139 may be lengthened or shortened,widened or narrowed, or positioned closer together or further apart asdesired. It will be appreciated that in at least one exemplaryembodiment the shape and spacing of the protrusions 137, 139 may be suchthat very little space is left between them when the first and secondtoe box members 136, 138 are formed into the desired shape, as a way ofproviding further protection of the toes while still having somebreathability in the toe and ball of foot area as with the apertures 42,44, 46, 72, 74, 76 formed in the first and second shell members 30, 60.Once again, a variety of such configurations of the toe box 130 and itsfirst and second toe box members 136, 138 are possible according toaspects of the present invention without departing from its spirit andscope. With continued reference to FIG. 13, there is also shown on theoutside of the bottom or back zipper assembly 100, along or overlappinga portion of both the first and second zipper strips 102, 104 and of theouter surfaces 134 of the toe box 130, or here of the opposite first andsecond toe box members 136, 138, opposite lengthwise strips ofrespective first and second attachment material 50, 80, which may runsubstantially the length of the back zipper assembly 100 at least fromits distal end associated with the toe box 130 and along the entireunderside of the apparatus shell members 30, 60 to and around the heelregion. As will be appreciated with reference to FIGS. 18-22, a varietyof non-slip or other such materials may then be selectively applied tothe bottom of the orthosis 20 via such first and second attachmentmaterial 50, 80 from the toe to heel to facilitate walking about on theorthosis 20 even without a cast shoe, walker boot, or the like, again,more about which is said below.

Referring briefly to FIG. 14, analogous to FIG. 2, there are shown sideelevation or flat views of the first and second shell members 30, 60 intheir flat or pre-formed state, as after manufacture but prior to use oreven completed assembly of the alternative exemplary orthosis apparatus20 of FIG. 13. The shell members 30, 60 may again be molded or formedinto any desired shape, here again being substantially symmetrical,though such is not necessary, particularly in other contexts, andemploying any appropriate material now known or later developed,including but not limited to the illustrative thermoformable substrate36, 66 that may be coated on one or both surfaces with a respectivecoating 56, 86 (FIGS. 21A-21C) such as silicone, polyurethane (“PU”), orany other such stretchable material now known or later developed. Here,it will be appreciated that while the area of the leg (calf and ankle)as relating to the first and second upper and intermediate apertureregions 42, 46, 72, 76 may be somewhat similar in size and configurationto that of the first exemplary embodiment of FIGS. 1 and 2, the area ofthe foot or the first and second lower aperture regions 44, 74 may berelatively shorter, allowing for more of the forefoot and toe region tobe supported by the alternative exemplary toe box 130 (FIG. 13) andthereby allowing for relatively increased and/or easier size adjustmentacross the typical population, without the complication andinconvenience of trimming of any thermoformable material, which againpresents particular challenges around the zipper assemblies 90, 100,more about which is again said below in connection with FIGS. 18A and18B. Those skilled in the art will of course again appreciate that therelative sizes of the different regions 42, 44, 46, 72, 74, 76 in theexemplary AFO apparatus 20 may vary widely, as can the clinicalapplications beyond ankle-foot and thus the overall configuration of theapparatus 20 accordingly. As such, it will again be appreciated that thedrawings are schematic in nature and are not to be taken literally or toscale in terms of material configurations, sizes, thicknesses, and otherattributes of an apparatus 20 according to aspects of the presentinvention and its components or features unless specifically set forthherein. In the context of such molded or otherwise formed flat “blanks”of the first and second shell members 30, 60 and the exemplary “medium”sized orthosis apparatus 20 according to aspects of the presentinvention, and by way of further illustration and not limitation, flatmeasurements such as of the shell 30, 60 in its pre-formed state asshown in FIG. 14 are an overall height of approximately 480 mm, anoverall width of approximately 280 mm, a width at the upper end 22 ofapproximately 180 mm, and a width at the lower end 24 of approximately125 mm. Staying with the exemplary “medium” sized orthosis, theeffective inseam length along the selectively adjoining front edges 38,68, which is essentially also the length of the upper zipper assembly90, is approximately 490 mm, and the effective inseam length along theselectively adjoining back edges 40, 70, which is also the length ofthat portion of the back zipper assembly 100 attached to the shells 30,60 at the back edges 40, 70, is approximately 710 mm, with the overalllength of the back zipper assembly 100 being approximately 910 mm long,thus including a free portion of the back zipper assembly 100 thatextends beyond the lower ends 34, 64 of the shells 30, 60 to accommodateinstallation of the opposed first and second toe box members 136, 138 ofthe alternative toe box 130 as herein described, which toe box members136, 138 would thus in the exemplary “medium-sized” embodiment have aflat or unformed length (as in the condition illustrated in FIG. 15) ofapproximately 200 mm, which is roughly the difference between theoverall length of the back zipper assembly 100 of 910 mm and theeffective inseam length along the selectively adjoining back edges 40,70, which is also the length of that portion of the back zipper assembly100 attached to the shells 30, 60 at the back edges 40, 70, ofapproximately 710 mm (i.e., 910 mm-710 mm). It will be appreciated thatthe two toe box members 136, 138 may be substantially coterminous withthe distal end of the back zipper assembly 100 or may be short of thatdistal end to some extent, such that there is a portion of the backzipper assembly 100 that extends distally beyond the toe box 130, or thetoe box members 136, 138 specifically, as shown elsewhere. Regarding thetoe box members 136, 138, in one exemplary embodiment the overalllateral width of each is approximately 60 mm, roughly 15 mm of which maybe the protrusions 137, 139. Once again, those skilled in the art willappreciate that all such arrangements and dimensions are merelyillustrative of features and aspects of the present invention andnon-limiting.

Turning next to FIG. 15, analogous to FIG. 3, the alternative exemplaryorthosis apparatus 20 according to aspects of the present invention asshown in FIG. 13 is here shown still in its flat or pre-formed state,with the respective first and second shell members 30, 60 now assembledas through the opposed front and back zipper assemblies 90, 100, thushere only the second shell member 60 being visible as being laid over onthe first shell 30 from the orientation of FIG. 14, with the symmetricalsecond shell member 30 lying directly therebeneath in this view. Thezipper assemblies 90, 100 are attached to the opposed shells 30, 60,whether the substrates 36, 66 themselves or any coating 56, 86 appliedthereto (FIGS. 21A-21C), though again other fastening devices and meansfor their attachment to the shells 30, 60, whether now known or laterdeveloped, may be employed. Here, with reference also to FIG. 13, thefront zipper assembly 90 is again positioned at the front of theapparatus 20 or across the top of the foot and up the front of the legor shin, and the back zipper assembly 100 is positioned at the back ofthe apparatus 20 or across the bottom of the foot, around the heel, andup the back of the leg or calf. Once more, while zippers or otherfasteners are shown as being under the foot and at the back of the legand across the top of the foot and at the front of the leg,substantially opposite one another, which has anatomical and use-relatedbenefits as herein described, it will be appreciated that otherlocations and arrangements of such two or more zippers or the like maybe employed according to aspects of the present invention withoutdeparting from its spirit and scope, noting that other offsetarrangements of such closures would still provide the desired hingingand sufficient opening and access. Notably, in the alternative exemplaryembodiment, each toe box member 136, 138 may be attached to itsrespective zipper strip 102, 104 employing any suitable means now knownor later developed, again in much the same way that the zipper strips102, 104 may be attached to or embedded in the respective shells 30, 60,particularly where the toe box members 136, 138 are formed of athermoformable material, perhaps the same as or similar to that of theshells 30, 60. Accordingly, the back zipper assembly 100 may again beinstalled here on the opposed toe box members 136, 138 as by effectivelybonding or embedding the respective zipper strips 102, 104 to or withinany coating material applied to the toe box members 136, 138 whenuncured. In a further exemplary embodiment, a two-sidedpressure-sensitive adhesive (“PSA”) tape may be employed between therespective zipper strips 102, 104 and the underlying edges of the toebox members 136, 138, whether such toe box members 136, 138 or thesubstrates thereof are coated or not. When a silicone coating is appliedto the toe box members 136, 138, such PSA tape may be formed having anacrylic or rubber-based side facing the zipper strips 102, 104 and asilicone side facing the silicone-coated toe box members 136, 138. If aPU elastomer coated toe box member 136, 138 is used, a rubber-based orPU-based side of the PSA tape is affixed to the PU coated toe box member136, 138 while the acrylic or rubber-based adhesive side is again facingthe zipper strips 102, 104. Or alternatively, in a still furtheralternative exemplary embodiment, if a PU elastomer coated toe boxmember 136, 138 is used, a PU PSA tape can be bonded to both the PUcoated toe box members 136, 138 and the zipper strips 102, 104, as thePU PSA generally would stick to both such surfaces. In still furtherembodiments, velour tape with an adhesive backing may be applied at theedges of the respective toe box members 136, 138, with the zipper strips102, 104 attached via a mushroom hook to the velour. Again, thoseskilled in the art will appreciate that any and all such attachmentmeans now known or later developed may be employed according to aspectsof the present invention without departing from its spirit and scope. Byway of further illustration and not limitation, double-sided tape in avariety of forms, stitching, in-tool over-molding, hot melt, hotlaminating, solvent or other bonding, ultrasonic welding, and/or Velcro®hook-and-loop fasteners may be employed in operably securing the toe boxmembers 136, 138 on the back zipper assembly 100 without departing fromthe spirit and scope of the invention. With continued reference to FIG.15, those skilled in the art will once again appreciate that for thesecond toe box member 138 that is visible in this view, and thus themirror-image first toe box member 136 (FIG. 13) that is positionedimmediately and symmetrically beneath the second in the exemplaryembodiment, each such toe box member 136, 138 is formed initially as asubstantially flat and somewhat rectangular body having a straight edgealong which the respective first and second zipper strips 102, 104 arejoined and further having a plurality of laterally-extending,spaced-apart protrusions 137, 139 opposite of the respective firstzipper strips 102, 104. As noted previously, the size and spacing andthus overall configuration of such protrusions 137, 139 may vary widelybased on a number of factors, including the sizing of the overallorthotic 20 and its intended use, such that the exemplary protrusions137, 139 are to be understood as illustrative and non-limiting. As alsoappreciated from the present side view of the unformed apparatus 20,there is shown a small gap between the proximal end of the toe box 130and the body of the orthosis 20, here specifically the second toe boxmember 138 and the second shell member 60, which it will be appreciatedfacilitates the hinged movement of the toe box 130 relative to the bodyof the orthosis 20 as herein described as being at least about the backzipper assembly 100 as a “living hinge.” In one exemplary embodiment,the gap between the toe box 130 and the body of the apparatus 20 isapproximately 2 mm, though this is merely illustrative and non-limiting.While not shown, one or more additional breaks in the first and secondtoe box members 136, 138 to further facilitate flexing, hinging, orother articulation of even the formed toe box 130 are possible accordingto aspects of the present invention without departing from its spiritand scope.

Shifting now to FIGS. 16 and 17 and the alternative exemplary orthosisapparatus 20 according to aspects of the present invention in use,analogous to the perspective views of the first exemplary embodiment ofFIGS. 5 and 6, first, as seen in FIG. 16, with the apparatus 20 heatedto a forming temperature such as in the range of 50−80° C., with furtherreference by way of illustration and not limitation again to U.S. Pat.Nos. 7,985,192 and 8,853,603, it is malleable and able to be draped overthe limb to begin the fitment process, generally as described previouslyherein. The limb or area to be treated such as a lower leg L (ankle andfoot area) is prepped as by applying a sock S thereover as shown or anyother stocking, wrap, padding or the like as may be prescribed by theclinician. An optional inflation bladder 160 or cold therapy pad 170 mayalso be applied to the treatment site, more about which is said above inconnection with FIGS. 11 and 12. Here, an insole 140 is also placedwithin the orthosis apparatus 20 beneath the patient's foot F as shown,generally in its unformed state. Where the insole 140 is also formed inwhole or in part of a thermoformable material, more about which is saidbelow in connection with FIGS. 23-26, the orthosis apparatus 20 togetherwith the insole 140 may be heated employing any appropriate means, withthe opposed flat shells 30, 60 zipped or attached together as shown inFIG. 15, or even as provided folded in half as shown an described inconnection with the first exemplary embodiment of the apparatus 20 inFIG. 4. Once activated, or heated and malleable, the back zipperassembly 100 is opened typically at least halfway down, such as to theregion of the heel to facilitate easy application onto the limb(typically while the patient is sitting down facing the clinician), itbeing appreciated that leaving the lower portion of the back zipperassembly 100 zipped forms a nest or bottom area of the orthosis 20against which the foot F and the insole 140 may be seated as the upperend 22 is pulled proximally to position the orthosis 20 as shown in FIG.17. Again, if an insole 140 is employed, it is placed between the bottomof the patient's foot F and the bottom of the orthosis 20, which it willbe appreciated serves at the very least to provide additional paddingbetween the bottom of the foot F and the bottom portion of the backzipper assembly 100. As shown, the insole 140 is initially substantiallyflat and somewhat foot-shaped having an upwardly-facing surface 142 thatis to be oriented toward the foot F of the patient and an oppositedownwardly-facing surface 144 that in use is oriented toward the bottomof the orthosis 20 or against a portion or lower end section of the backzipper assembly 100 for comfort; as such, it will be appreciated thatthe insole 140 may be monolithic or formed from a single materialthroughout or may formed in layers or otherwise from two or morematerials, such that the opposed upwardly-facing and downwardly-facingsurfaces 142, 144 may not be the same material or construction, as willbe further appreciated from the alternative exemplary insoles 140 shownand described below in connection with particularly FIGS. 24 and 25.Furthermore, though the insole 140 is shown as being flat and of aparticular thickness, it will be appreciated that it may be thicker orthinner as desired and may be pre-formed with a prescribed shape, suchas having an arch support area or heel well. Alternatively, suchtopographical surface features may be formed in the insole 140 duringuse, or specifically during forming, as in the case where the insole140, as with the toe box 130 and the orthosis halves 30, 60 themselves,is made of or comprises, at least in part, a thermoformable material.Here, such a thermoformable insole 140 would again be heated along withthe orthosis apparatus 20 to render it malleable as well prior toplacement for optimum anatomical conformity. Once the apparatus 20including the toe box 130 and any optional accessories such as theinsole 140 are so activated and positioned, the back zipper assembly 100is substantially closed as by pulling the back top zipper pull 106 (FIG.13) upwardly toward the upper end 22 of the orthosis 20, which causesstretch zones as formed by the apertures, particularly the upperapertures 42, 72, to stretch to allow the zipper 100 to fully close.Again, both zipper pulls 106, 108 at both ends can be adjusted back, orunzipped slightly, to allow folding of the ends 22, 24 to provide acomfort edge around the toes T and leg L as by setting the correctlength below the knee. It is also at this stage that the clinician wouldfold or bend the activated, malleable toe box 130 comfortably around thetoes T and back onto the apparatus as shown and described in connectionwith FIG. 13 in an illustrated position of the apparatus 20 and soaffixed or held in that position as by removably mating or engaging theback first and second zipper strip fastener members 112, 114 formed onthe underside of the respective first and second toe box members 136,138, or more particularly on the respective back first and second zipperstrips 102, 104, with the respective first and second shell fastenermembers 48, 78 formed on the upper side of the respective shell members30, 60 on opposite sides of the front zipper assembly 90, or moreparticularly along the respective front first and second zipper strips92, 94. Those skilled in the art will also appreciate in this contextthat should any portion of the activated, formable toe box members 136,138 be in contact with the activated, formable shell members 30, 60, inan exemplary embodiment, due to any silicone or other such coating onthe shells 30, 60 and/or the toe box members 136, 138 such componentswould not stick to each other, allowing for the hardened components tostill move relative to one another, such as in selectively hinging thetoe box 130 open as shown in FIG. 17 as by disengaging the tox boxVelcro® swatches 112, 114 from the shell Velcro® swatches 48, 78. Hereand generally across all embodiments, it is again noted that whileVelcro® type “hook-and-loop” fasteners are shown and described, otherfastening means now known or later developed may be employed. Moreover,in the Velcro® context the locations of the “hook” portions and “loop”portions may vary without departing from the spirit and scope of theinvention. In the formed position of the apparatus 20 essentially asagain shown in FIG. 13, as it continues to cool and set, but while stillmalleable, the patient may then stand on the affected foot F and leg Lso as to further shape and form not only the apparatus 20 including thetoe box 130 as they are manipulated exteriorly by the clinician, butalso the interior insole 140 as it is effectively shaped along with thebottom of the apparatus 20 by the patient's anatomy and weight, in whichway it is also ensured that the foot angle and position of the orthosisapparatus 20 is in a comfortable somewhat “neutral” position for thepatient before it fully sets and hardens, as further appreciated withreference to FIGS. 18A and 18B. Those skilled in the art will thusappreciate that the resulting formed and hardened apparatus 20,including the toe box 130 and insole 140, substantially conforms to thepatient's anatomy, here the leg L and foot F. In terms of fitment of theintegrated thermoformable toe box 130, specifically, as best seen inFIG. 17, such is again curved or bent along its length, or along theopposed first and second toe box members 136, 138 to make such “toebox,” with such bend location being set based essentially on the lengthof the patient's foot F and thus the position of the patient's toes Trelative to the open lower end 24 of the apparatus 20, as well as anyinsole 140 that may be employed. The toe box 130 so formed, bothinitially during forming and then once hardened during use as when thetoe box 130 is hinged open or closed as shown in FIG. 17, may again beselectively held in place on or relative to the body of the orthosisapparatus 20 employing a variety of means now known or later developed.In the exemplary embodiment, once more, first and second zipper stripfastener members 112, 114 are formed on the inside or upwardly facingsurface of the free end of the back zipper assembly 100, or alongopposite first and second zipper strips 102, 104 at the distal end ofthe zipper assembly 100, and similarly first and second shell fastenermembers 48, 78 are formed or applied on the upwardly-facing lower endportion of the orthosis 20, one on each of the first and second shells30, 60, or specifically along opposite front first and second zipperstrips 92, 94. It will be appreciated that the toe box 130 may itself bea hook-and-loop material, or have such swatches formed, on the innersurfaces 132 of the opposite first and second toe box members 136, 138capable of selectively engaging the orthosis swatches 48, 78 so that thetoe box 130 may be selectively folded up and over the otherwise openlower end 24 of the orthosis 20 and held in position as shown in FIG.13. Alternatively, the toe box 130 may be formed comprising oppositefirst and second toe box members 136, 138 made of a thermoformablematerial to which Velcro® swatches are affixed, such a thermoformabletoe box being shaped as explained herein. Either way, it will beappreciated that in the exemplary embodiment, the extended zipper 100 onthe lower end 24 of the AFO 20 facilitates attachment or integration ofthe toe box 130 so that the zipper 100 is neatly anchored on the topside of the foot F in use as shown in FIG. 13, which has severaladvantages in that the zipper would be uncomfortable or subject todamage, particularly as to its one or more pulls 106, 108, if left onthe sole of the foot, the zipper 100 thereby assisting in anchoring thetoe box 130 in position to protect the toes T, and the zipper extension100 in combination with the toe box 130 facilitates the accommodation ofdifferent foot lengths and removes the need for trimming, which wouldmake the zipper configuration relatively complex to allow for differentfoot lengths if trimmed also. For a total contact cast (“TCC”) fordiabetic foot ulcer treatment, the toe box 130 being made from athermoformable substrate or other such material again provides increaseddurability, protection, and compliance. Relatedly, it will beappreciated that in use such toe box 130 not only protects the toeregion T but selectively provides access thereto by simply disengagingor detaching the toe box 130 and/or zipper 100 from the top of theorthosis apparatus 20, the alternative toe box 130 otherwise remainingengaged with the apparatus 20 and effectively hinging about the backzipper assembly 100 and any optional strips or patches of first andsecond reinforcing material 52, 82 applied over or spanning the bottomjoint between the shell members 30, 60 and the respective first andsecond toe box members 136, 138, which it will be appreciated not onlyprovides further structural integrity at the hinge, particularly againstany twisting between the toe box 130 and the first and second shells 30,60 about the back zipper assembly 100, but also renders the jointbetween such shells 30, 60 and the toe box 130 relatively “seamless” andmore comfortable, particularly in cases where no insole 140 is employed.Again, those skilled in the art will appreciate that selective openingand closing of the integrated toe box 130 as by hinging about the baseof the orthosis 20 at its lower end 24 so as to selectively open suchend 24 allows the clinician to inspect the toes T for good circulationor other indicia of health without removal of the orthosis 20, which isparticularly handy in cases where a security strap 190 is employed, moreabout which is said below in connection with FIG. 22. If an inflationbladder 160 was fitted, it may be inflated/deflated to provide comfortand adjustment for swelling, more about which is again said above withreference to FIG. 11. To remove the exemplary AFO apparatus 20 as toevaluate the treated area or limb or administer therapy, for example, aclinician would simply unzip both zippers 90, 100 and remove the shells30, 60, and to then refit or install the AFO 20, the shells 30, 60 areplaced back in position and zipped back up. More specifically, to removethe device 20, the front zipper assembly 90 is fully opened and the backzipper 100 is opened downwards to the heel such that the two opposedshells 30, 60 may now hinge open to allow for easy insertion and removalof the limb while remaining connected as a single device 20 for easyrefitting later, including with the hinged toe box 130 and any insole140 nested in the closed zipper region at the base of the foot.

Referring next to FIGS. 18A and 18B, there are shown side elevationschematic views of the alternative exemplary orthosis apparatus 20according to aspects of the present invention in two illustratedoperational modes, or essentially two different size configurations ofthe otherwise same orthosis 20. In both, the view is taken across thevertical mid-plane of the device at the front and back zipper assemblies90, 100, with the second shell member 60 removed or cut away for ease ofviewing into effectively the cross-section of the first shell member 30.As such, it will be appreciated that in each view there is shown theorthosis first shell member 30 with its front and back zipper assemblies90, 100, the back zipper assembly 100 again terminating distally in thenow-formed integral toe box 130, here there being seen the first toe boxmember 136 as herein described. The optional first attachment material50 is also shown in these views as installed along the back zipperassembly 100 from its distal end at least roughly to the heel region ofthe apparatus 20, more about which is said below in connection with FIG.19. As also shown again here in FIGS. 18A and 18B, a first reinforcingmaterial 52 may be applied across the joint between the toe box 130 andthe body of the apparatus 20, or here between the first toe box member136 and the first shell member 30, so as to provide integrity andcomfort at the transition from the body to the toe box 130, which againis effectively a “living hinge.” In this regard, it will again beappreciated that the drawings are schematic in nature and no suchcomponents should be taken from the drawings as being dimensionally orproportionately accurate or literally to scale. Indeed, regarding thereinforcing materials 52, 82, such are likely relatively thin andprovide a smooth transition across to the toe box 130, it beingappreciated by those skilled in the art generally and even withreference to the schematic side views of FIGS. 18A and 18B that thebottom of each shell member 30, 60 is in the exemplary embodimentsubstantially coplanar with the bottom portion of the toe box members136, 138 for a relatively continuous and somewhat flat bottom of theorthotic 20 from heel to toe, with no noticeable or significant steps orchanges in elevation, particularly again at the transition to the toebox 130, it being further appreciated that any variations may also beaccounted for through an employed insole 140 (FIGS. 16 and 17), or insome cases a bottom rocker feature 26 (FIG. 23) may be formed in theorthosis 20 via a corresponding rocker member 154 of an alternativeinsole 140 (FIGS. 23-25), more about which is said below. In regards tosizing, once more, it is expected that generally three nominalsizes—“small,” “medium,” and “large”—would be provided to cover asubstantial portion of the target (e.g., adult) population (e.g., 95%conformity). Again, here, for purposes of illustration, the apparatus 20shown and described is in connection with such a “medium” sized AFO.Taking typical U.S. foot or shoe sizes, such a “medium” orthosis 20 mayaccommodate the range of size 7 to size 10, as compared to a “small”covering sizes 3 to 6 or a “large” covering sizes 11 to 13, forexample—again, all such sizing being illustrative and non-limiting.Continuing with the “medium” sized AFO example, and with reference toFIG. 14 as well and the related discussion above, the foot portions orfirst and second lower aperture regions 44, 74 of the apparatus 20 mayroughly set a “heel to toe” length on the small end of the range, inthis example a shoe size 7, further accounting for a bit of the toes Tand any insole 140 (FIGS. 16 and 17) to be positioned just beyond thelower end 24 of the apparatus 20 and thus within the toe box 130. Assuch, with reference first to FIG. 18A, it will be appreciated that toadjust or customize the exemplary medium-sized AFO apparatus 20 to thesmall end of its range, during the formation and fitment processexplained above, the clinician would fold or bend the then-malleable toebox 130 relatively tightly to the lower end 24 of the apparatus 20 andaffix the free end of the toe box 130 and back zipper assembly 100relatively higher up the forefoot area of the apparatus 20, herespecifically as shown in connection with the first shell member 30 as byremovably engaging the back first zipper strip fastener member 112 (FIG.18B) formed on the inside surface 132 of the first toe box member 136and/or on the back first zipper strip 102 (FIG. 16) of the back zipperassembly 100 with the first shell fastener member 48 (FIG. 18B) formedalong the front first zipper strip 92 (FIG. 17) of the front zipperassembly 90 at the forefoot region of the first shell member 30. Thoseskilled in the art will appreciate that by forming a tighter curve inthe toe box 130 during fitment and so attaching the toe box higher upthe AFO body, the overall “heel-to-toe” length of the AFO apparatus 20is thus rendered relatively smaller, again, something on the order of anadult size 7 in the “medium” sized AFO example. By comparison, withreference now to FIG. 18B, the exemplary medium-sized AFO apparatus 20is here fitted to the large end of its range, wherein once again duringthe formation and fitment process explained above, the clinician wouldfold or bend the then-malleable toe box 130 relatively loosely beyondthe lower end 24 of the apparatus 20 and affix the free end of the toebox 130 and back zipper assembly 100 relatively lower down the forefootarea of the apparatus 20, again here in connection with the first shellmember 30 as by removably engaging the back first zipper strip fastenermember 112 formed on the inside surface 132 of the first toe box member136 and/or on the back first zipper strip 102 (FIG. 16) of the backzipper assembly 100 with the first shell fastener member 48 formed alongthe front first zipper strip 92 (FIG. 17) of the front zipper assembly90 at the forefoot region of the first shell member 30. Here, it will beappreciated that by forming a looser or more distal curve in the toe box130 during fitment and so attaching the toe box lower on the AFO body,the overall “heel-to-toe” length of the AFO apparatus 20 is thusrendered relatively larger, here something on the order of an adult size10 in the “medium” sized AFO example. It will be appreciated by thoseskilled in the art that an AFO apparatus 20 according to aspects of thepresent invention is thus capable in only a few manufactured sizes orconfigurations of covering a large percentage of the target population,considering that the apparatus 20 is ambidextrous or works for right orleft applications, as also may be true for the insole, with particularreference to FIG. 26 and the related discussion below, and that thecustom formable hinged toe box 130 can be fitted as desired to cover arange of sizes or foot lengths, not to mention again the custom formingof the overall orthosis 20 as described herein to account for otheranatomical variance across the population. As such, there is providedaccording to aspects of the present invention a highly adaptable anduniversal orthotic apparatus 20, which may be varied in configurationand sized or scaled up or down to accommodate a wide array ofapplications beyond the exemplary human lower leg context.

Briefly, turning to FIG. 19 there is shown a bottom perspective view ofthe alternative exemplary orthosis apparatus 20 according to aspects ofthe present invention here showing first and second strips of non-slipmaterial 54, 84 selectively applied along the bottom of the orthosis 20as by being removably engaged with the respective first and secondstrips of attachment material 50, 80 applied along the length of theback zipper assembly 100 (FIGS. 17 and 18) at least from its distal endassociated with the toe box 130 and along the entire underside of theapparatus shell members 30, 60 to and around the heel region. Suchnon-slip materials 54, 84 may take a variety of types and forms, suchthat the parallel, lengthwise strips are to be understood as merelyillustrative and non-limiting. By way of further illustration and notlimitation, rather than two separate, spaced-apart strips 54, 84, asingle wider strip spanning both shells 30, 60 and thereby covering theback zipper assembly 100 completely in the region beneath such non-slipmaterial is also possible. And while any such non-slip materials 54, 84are shown as themselves being formed on their opposite sides withVelcro® hook-and-loop material so as to removably engage the respectivestrips of attachment material 50, 80, other means of engagement of suchnon-slip material with the orthosis 20, whether temporary or permanentand whether now known or later developed, may be employed according toaspects of the present invention without departing from its spirit andscope. One exemplary material that may be employed as such non-slipmaterial(s) 54, 84 is Vibram® manufactured by Vibram S.P.A. in Italy,though again, a wide variety of materials, now known or later developed,may be employed. In the exemplary embodiment, both the non-slip strips54, 84 and the associated attachment strips 50, 80 are on the order of80 mm wide, though it will be appreciated that such is merelyillustrative and non-limiting. As also seen in FIG. 19, optionally,first and second reinforcing materials 52, 82 may be applied at thejoint or hinge connection between the body of the AFO apparatus 20 andthe toe box 130 on the outside of the shells 30, 60 and respective toebox members 136, 138 instead of or in addition to at the joint on theinside of the apparatus 20 as shown in FIG. 16. Relatedly, in thepartial side schematic views of FIGS. 20A and 20B, somewhat analogous tothat of FIG. 18A, there are shown an exemplary such orthosis apparatus20 with either no separate non-slip material, instead the material ofthe shell 30 or any coating thereon supplying such properties as in FIG.20A, or having a non-slip material 54 applied as by Velcro® to anunderlying attachment material 50 as in FIG. 20B, there the non-slipmaterial 54 going from heel to toe of the orthosis 20 as in FIG. 19.

Turning next to FIGS. 21A-21C, there are shown various enlargedcross-sectional views taken from the associated section lines in FIG. 10demonstrating exemplary construction and layering of the orthosis 20,generally and in the region of any fastening or closure means such as azipper. As a threshold matter, it is noted that the sections happen tohave been taken substantially at the upper end 62 of the second shellmember 60, it being appreciated that the shells 30, 60 again beingsymmetrical such that such structure is representative of the firstshell member 30 as well, and of the various alternative embodiments ofthe AFO apparatus 20, though not necessarily so. First, in FIG. 21A,there is shown a partial end cross-sectional view illustrating a portionof the thermoformable substrate 66 having applied on its inner and outersurfaces a coating 86. As with the other figures, it is again noted thatsuch are schematic in nature and not to be taken literally or to scalein terms of material configurations, sizes, thicknesses, and otherattributes. By way of illustration and not limitation, the nominalsubstrate thickness may be in the range of 2 to 8 mm generally, ornominally 5 mm, versus closer to 2 mm such as at the indented malleolirings, while the coating thickness may be in the range of 40 to 200 μm,or nominally or in some cases preferably 80 μm. As such, those skilledin the art will appreciate that the coating 86 is generally on the orderof one hundred to one thousand times thinner than, or dimensionally isan order of magnitude of one hundred to one thousand different from, thesubstrate 66. As seen in FIGS. 21B and 21C, sectional views taken alongan edge of the shell, here the second back edge 70 of the second shell60, though again the shells 30, 60 being symmetrical such that similarsections would be formed in the other three shell edges 38, 40, 68, theedge region 70 may be thicker to increase stiffness or structuralintegrity or rigidity in that region, at least relative to the main bodyof the shell 60, so as to maintain the lengthwise edges of the shell 60or render them substantially non-stretching so as to prevent detachmentof the zipper assembly 100, or the back second zipper strip 104 in theexemplary sectional view, from the shell 60. Such exemplary reinforced(thicker) lengthwise edges 38, 40, 68, 70 of the two halves 30, 60 wherethe zipper assemblies 90, 100 are attached thus yield reduced stretchand increased stiffness and zipper retention—the device engineered tonot stretch appreciably in those lengthwise regions even when heated.Alternatively, in a further exemplary embodiment, not shown, the edgeregions taper down from the nominal 5 mm substrate thickness, such as to3 mm, which thinner edge region may assist in zipper attachment andretention. As such, it will be appreciated that according to aspects ofthe present invention the rounded edge region may be thicker or thinnerand/or wider or narrower as needed. As explained elsewhere herein,attaching the zipper assemblies 90, 100 to the shells 30, 60 orsubstrates 36, 66 may be achieved in a number of ways now known or laterdeveloped, including but not limited to a pressure sensitive adhesive(“PSA”) 120 as shown in FIG. 21C, which may be single width strips oneach side of the substrate 66 or, as shown, a double-wide strip thatwraps the edge so as to simultaneously be applied to both the inner andouter surfaces of the substrate edge, as particularly advantageous wherethe zipper assembly 100 is attached on both the inner and outer surfacesas by positioning inner and outer zipper strips 104 therealong. Thewidth of the cloth material or zipper strips 92, 94, 102, 104 issubstantially non-stretchable in the exemplary embodiment, which aloneor in conjunction with the edges 38, 40, 68, 70 again effectivelycreates a non-stretch area laterally on the edges of the shells 30, 60.By engineering the width of this area there is created a “non-stretch”area of the shells 30, 60 in the exemplary embodiment that provides aminimum strength and rigidity of the device 20 after molding on apatient. Once more, any other suitable or relatively non-stretch closuremeans now known or later developed may be employed in selectivelyjoining the opposed edges 38, 40, 68, 70 of the respective first andsecond shell members 30, 60, such that the zippers 90, 100 are to beunderstood as illustrative and non-limiting. Furthermore, in alternativeembodiments both the closure means and the lateral shell edges may alsobe stretchable when the shells are activated or heated for forming justas across the bodies of the shells, with such lateral areas stillstiffening once the shells harden and set.

Referring briefly to FIG. 22, there is shown a perspective view of astill further alternative exemplary orthosis apparatus 20 according toaspects of the present invention, analogous to that of FIG. 13 with afew notable differences. First, it is simply observed that an insole 140is shown as positioned within the apparatus 20 as is visible throughopenings in the closed toe box 130. Second, a single strip of non-slipmaterial 54 is applied to the bottom of the apparatus 20 substantiallyfrom “heel-to-toe” and from “side-to-side,” which material 54 may againbe affixed as by Velcro® employing the first and second attachmentmaterials 50, 80 incorporated into the apparatus 20 as herein described,and any other such attachment material portions (not shown), asappropriate, or by any other temporary or permanent means now known orlater developed, including directly incorporating such material 54 intothe shells 30, 60 themselves during production. And third and somewhatrelatedly, an optional strap 190 is shown as being applied about theforefoot or over the top of the closed toe box 130 for additionalstrength and integrity. Such strap 190 may be integrally formed with theapparatus 20, or the respective shells 30, 60 thereof, regardless may bepositioned above or below any non-slip material 54 applied to the bottomof the apparatus 20, or may simply be applied about the apparatus 20 ina secondary step but otherwise not directly affixed to the apparatus 20.In the exemplary embodiment, such strap 190 is shown as being above thenon-slip material 54, or positioned between the non-slip material 54 andthe bottoms of the opposite shells 30, 60, for further securement of thestrap 190, though again such is not required. Such strap 190 maygenerally comprise a strap body 192 and a D-loop bracket 194 about whichthe strap body 192 is slidably engaged for tightening down and securingthe strap 190 in a manner generally known, as may entail a textile andVelcro® based strap or any other suitable materials now known or laterdeveloped. In a particular exemplary embodiment, such strap 190 may beconfigured as a so-called “compliance strap” such as disclosed inapplicant's U.S. Pat. No. 8,821,423, incorporated herein by reference,whereby the security strap 190 may be wrapped and secured about theorthosis 20 as shown to prevent tampering with or unauthorized removalof the orthosis 20, in which case such strap 190 may be secured to theorthosis 20 directly or may be retained on the orthosis 190 as by theoptional non-slip material 54. Or, a separate compliance strap (notshown) as per the '423 patent may be employed in the ankle or smallestcircumference region of the orthosis 20 above the ankle so as to furtherinsure that the compliance strap cannot be removed without beingdestroyed, thereby again preventing tampering with or unauthorizedremoval of the orthosis 20. While the strap 190 may be configured in avariety of ways and sizes in terms of length and width, in an exemplary,non-limiting embodiment the strap body 192 is approximately 40 mm wide,which it will be appreciated would substantially cover the free end ofthe toe box 130, or the end folded over the forefoot of the body oforthosis apparatus 20, to render the overall apparatus 20 relativelyrigid and sturdy.

Turning next to FIG. 23, there is shown a partially cut-away perspectiveview of yet another alternative exemplary orthosis apparatus 20according to aspects of the present invention, again generally analogousto that of FIG. 13, here with an alternative insole 140 configured toform a somewhat downwardly protruding bottom rocker feature 26 in thebottom of the apparatus 20, which it will be appreciated can serve tofurther offload a particular area of the apparatus 20 and thus the footF therein as deemed appropriate by the clinician. For simplicity here inFIG. 23, the insole 140 is shown as comprising a single layer 148 of acompressible and/or moldable material that runs the “heel-to-toe” lengthof the orthosis 20 and has affixed or attached to its bottom surface,temporarily or permanently, a somewhat rigid rocker member 154 andassociated rocker base 152. Those skilled in the art will appreciatethat by placing such a rigid rocker member 154 beneath the insole 140,during forming of the orthosis 20 as above described, such rocker member154 will thus form or cause to be formed, in cooperation with theclinician's manipulation and fitment of the orthosis 20 on the leg L ofthe patient, a similar protrusion or rocker feature 26 at the bottom ofthe orthosis 20, which once fully hardened and in use results inselective offloading of an affected area of the foot F. As such, thebottom rocker feature 26 is effectively formed in the orthosis 20 fromthe inside thereof, or interiorly, as again by the incorporation of therocker member 154 within the insole 140, which has a number ofadvantages in practice. In a bit more detail, and now with reference tothe exploded side elevation view of an alternative exemplary insole 140in a pre-formed, unassembled state, the insole 140 comprises an upperlayer 146 and an intermediate layer 148 that together form thefull-length insole 140 and may be permanently integrated as by bonding,lamination, or the like, or may be removably engaged as by hook-and-loopfasteners, pressure-sensitive adhesives, or the like, as well as therocker member 154 here again either permanently or removably engageablewith a rigid rocker base 152. In the illustrated embodiment, the base152 may be removably engageable or selectively positionable relative tothe intermediate layer 148 and the rocker member 154 may be removablyengageable or selectively positionable relative to the rocker base 152,in all such cases employing any appropriate engagement means now knownor later developed. Those skilled in the art will thus appreciate thatsuch an arrangement related to the positioning of the rocker member 154relative to the overall insole 140 provides tremendous versatility tothe clinician in placing the rocker member 154 and thus forming thebottom rocker feature 26 in the orthosis 20 in the desired anatomicallocation. As an aside, where such an AFO apparatus 20 formed with abottom rocker feature 26 is to be worn inside a walker boot or cast shoeor the like (not shown), it will be appreciated that the insole of suchboot or cast shoe may be modified with adjacent, spaced-apart padsconfigured to straddle the rocker feature 26 and thereby allow forproper and comfortable seating of the orthosis 20 within the walker bootor cast shoe. In the exemplary embodiment, each of the four layers orcomponents comprising the insole 140 of FIG. 24 are temporarily joinedto the adjacent layer or component employing Velcro® hook-and-loopfasteners and/or related velour swatches, though again such is merelyillustrative and non-limiting. Continuing with the exemplary embodimentof FIG. 24, the intermediate layer 148 may be a custom moldablethermoplastic foam or the like, with the upper layer 146 formed of aclosed cell foam such as Plastazote®. Accordingly, and with briefreference now to FIG. 25A showing the alternative exemplary insole 140of FIG. 24 in its assembled and formed state, it will be appreciatedthat prior to formation of the insole 140 and thus of the overallorthosis 20, the rocker member 154 is again selectively positionablealong the rocker base 152 as illustrated, which rigid region of theinsole 140 would be less susceptible to deformation or to being trimmedto length as may be done at the free or opposite end of the insole 140,more about which is said below in connection with FIG. 26. By way offurther illustration and not limitation, and with continued reference toFIGS. 24 and 25A, the main or intermediate layer 148 of the insole 140may be on the order of 12 mm thick in its initial, unformed state, withthe Plastazote® or other such upper layer 146 maybe being on the orderof 4 mm thick. Similarly, the rigid rocker base 152 may be approximately4 mm thick compared to a rocker member 154 thickness or stand-off heightof roughly 15 mm, with the width and length of the rocker member 154being approximately 50 mm, again, just for illustration. Such rockerbase 152 and rocker member 154 may again be separate components as inFIGS. 24 and 25A or integral as shown in the alternative embodiment ofFIG. 25B, with any such rocker arrangements being interchangeable or“mixed and matched” with any such insole assemblies as involving upper,intermediate, or lower layers 146, 148, 150, as appropriate. Of course,a variety of other arrangements and numbers and configurations of suchlayers and components in forming the finished insole 140 are possibleaccording to aspects of the present invention without departing from itsspirit and scope. By way of further illustration and not limitation, informing the rocker member 154 and any related base 152 or other suchfeature, it will be appreciated that any appropriate materials andmethods of construction now known or later developed may be employed,including but not limited to metals such as steel, aluminum, alloys, andthe like and a variety of plastics such as polypropylene, polystyrene,polyvinyl chloride (“PVC”), acrylonitrile butadiene styrene (“ABS”),polyethylenes such as high density polyethylene (“HDPE”) and low densitypolyethylene (“LDPE”), polycarbonate, polyurethane, and other suchplastics, thermoplastics, thermosetting polymers, and the like, and evenwood, any such components being fabricated or formed as throughinjection molding, casting, extrusion, machining, stamping, routing,forming, or any other such technique now known or later developed.Relatedly, such components may again be formed integrally or may beformed separately and then assembled in any appropriate secondaryoperation employing any assembly technique now known or later developed,including but not limited to fastening, bonding, welding, over-moldingor coining, press-fitting, snapping, or any other such technique nowknown or later developed, or of course may be formed separately and thenconfigured for being removably rather than permanently engaged as setforth herein. Similarly, while a particular first exemplary embodimentin FIGS. 24 and 25A is shown and described, it will again be appreciatedthat an insole 140 according to aspects of the present invention may beformed of a variety of layers in terms of the materials, order in whichthe materials are layered, and the means of engaging the layers ofmaterial. Generally, materials such as polypropylene, Korex® or otherbrand closed cell vinyl foam, and ethylene vinyl acetate (“EVA”) may beemployed in such insoles 140, any of which potentially coated with orhaving a top layer or cover of Plastazote® or other brand closed cellcross-linked polyethylene foam, Procell® or other brand open cellpolyurethane foam, or Poron® or other brand microcellular polyurethanefoam. Indeed, with reference now to the further alternative exemplaryembodiment of FIG. 25B, the main portion of the insole 140 may insteadbe a three-layer construction, here comprising an upper layer 146 againof Plastazote® or other brand closed cell cross-linked polyethylenefoam, an intermediate layer 148 of Poron® or other such microcellularpolyurethane foam, and a lower layer 150 of ethylene vinyl acetate(“EVA”). Removably and repositionably affixed to the bottom surface ofthe lower layer 150 is an integral rocker base 152 and member 154 asindicated by the arrows in FIG. 25B. Once more, such removableengagement between such rocker assembly 152, 154 and the one or morelayers 146, 148, 150 together defining the insole 140 may be via anyappropriate means now known or later developed, including but notlimited to double-sided tape and Velcro® hook-and-loop fasteners. By wayof further illustration and not limitation, a two-sided tape (not shown)may be pre-installed, as during manufacturing, to the upwardly-facingsurface of the rigid rocker base 152, with its backing paper (not shown)peeled off to effectively activate the two-sided tape and allow therocker base 152 and integral rocker member 154 to then be located asdesired on the bottom of the insole 140's lower layer 150 in thisexample. In the exemplary embodiment, such rocker base 152 extendsapproximately 25 mm on either side of the rocker member 154. Once again,those skilled in the art will appreciate that a variety of otherconfigurations of an insole 140 and related components according toaspects of the present invention are possible, such that those shown anddescribed herein are to be understood as merely illustrative andnon-limiting. Back to the “offloading” characteristic of such insoles140, with or without the rocker member 154, as employed within anorthosis 20 according to aspects of the present invention as compared tothe offloading performance of regular walking shoes or to prior arttotal contact casts according to published data, the results of initialtesting are quite compelling as to the advantages of features andaspects of the present invention. By way of background, testing wasperformed using a third-party Pedar™ Pressure Mapping System to capturepeak plantar pressures at the forefoot, midfoot, and heel of aneighty-five kilogram (85 kg) subject wearing each orthotic in question,measured over at least thirty (30) steps. As a point of reference, whenthe subject wore a regular walking shoe, peak pressure measured at theforefoot was on the order of 310 to 360 kPa/cm², at the midfoot was onthe order of 110 to 160 kPa/cm², and at the heel was on the order of 245to 295 kPa/cm². Analogous published data for a typical “total contactcast” (“TCC”) indicates peak pressure measured at the forefoot ofapproximately 175 kPa/cm², at the midfoot of approximately 85 kPa/cm²,and at the heel of approximately 145 kPa/cm² (see, Polio, F. E., et al.,“Plantar Pressures in Fiberglass Total Contact Casts vs. a New DiabeticWalking Boot,” Foot & Ankle International, vol. 24, no. 1, 1 Jan. 2003,pp. 45-49; see also, Armstrong, David G., and Shea, Susan S., “TotalContact Casts and Removable Cast Walkers. Mitigation of Plantar HeelPressure,” American Podiatric Medical Association, vol. 89, no. 1,January 1999, indicating a TCC plantar heel pressure of approximately180 kPa/cm²). While the prior art “total contact cast” (“TCC”) wouldcertainly seem by all accounts to be an improvement over more typicalfootwear when it comes to pressure offloading, which is so important forpatients suffering from diabetic foot ulcers (DFU's) and other suchconditions of the plantar area of the foot, there is still room for muchimprovement, which need is met by an orthosis 20 according to aspects ofthe present invention. Indeed, by comparison, an AFO orthosis 20 such asshown in FIG. 13 having an insole 140 as in FIG. 25B was tested, withmuch improved plantar pressure offloading results—first, without theoptional rocker member 154, peak pressure measured at the forefoot wason the order of 125 to 175 kPa/cm², at the midfoot was on the order of70 to 120 kPa/cm², and at the heel was on the order of 160 to 210kPa/cm², and then with the optional rocker member 154, peak pressuremeasured at the forefoot was on the order of 80 to 130 kPa/cm², at themidfoot was again on the order of 70 to 120 kPa/cm², and at the heel wason the order of 125 to 175 kPa/cm². While these are relatively smallsample sizes and the test data performed with the Pedar™ PressureMapping System isn't necessarily the same in experimental design to thatof the TCC studies carried out and reported by Polio and Armstrong,there is initial good evidence that features of an orthosis 20 accordingto aspects of the present invention can indeed reduce, evensignificantly, peak plantar pressures, providing clinical benefits inuse, particularly when the optional rocker member 154 is employed, whichit will be appreciated uniformly engages the midfoot of a patient,thereby transferring forefoot and heel pressures to the midfoot, onwhich basis the forefoot and hell regions are offloaded. Once more,those skilled in the art will appreciate that a variety of otherconfigurations and combinations of an AFO orthosis 20 and any insole 140and rocker member 154 are possible according to aspects of the presentinvention without departing from the spirit and scope of the invention,through which still further offloading and other advantages may berealized. By way of further illustration and not limitation, thoseskilled in the art will appreciate that in particular contexts thecombination of an AFO orthosis 20 and an insole 140 with a rocker member154 may reduce any height difference between the affected foot with theorthosis 20 and the unaffected foot with conventional footwear, which itwill be appreciated even if small or subtle could make a noticeabledifference over time in terms of mitigating against other complicationsincluding spine, back, and hip pains, etc. in patients wearing casts andwalkers with relatively large height differences from one foot or leg tothe other.

Briefly and finally, referring to FIG. 26, there is shown a topelevation view of a still further exemplary insole 140 according toaspects of the present invention for use in an orthosis apparatus 20 asherein disclosed or otherwise, such insole 140 “blank” is substantiallyuniversal in that by flipping it one way or another horizontally orabout its lengthwise axis it can serve as or be used in both right footand left foot applications. Particularly, as shown, the insole 140, ofwhatever material(s) and construction, may be formed having a contourarea 156 such as having raised or pre-formed areas at the arch and/orheel cup. Also, such universal insole 140 may be further customizable asbeing trimmable to length and shape at its distal end, as indicated byand even having provided thereon one or more transverse trim lines 158to aid in such fitment by the clinician prior to placement of any suchinsole 140 within the orthosis apparatus 20 (e.g., FIGS. 1 and 13).

It can be appreciated from the foregoing that an insole 140 according toaspects of the present invention in any of the material and layerconfigurations described herein or otherwise, and with or without theoptional attachable rocker 154, could also be fitted inside a plaster orfiberglass cast (not shown) during forming to impart and achieve atleast some of the same beneficial offloading and pressure distributioneffects as achieved by the custom moldable AFO orthosis 20 describedherein. More generally, those skilled in the art will again appreciatethat various combinations of features of one or more components of anapparatus 20 according to aspects of the present invention may becombined in a number of other ways beyond those shown and describedwithout departing from the spirit and scope of the invention.

Aspects of the present specification may also be described as follows:

1. An orthosis apparatus comprising: a first shell member and an opposedsecond shell member, the first shell member having a first front edgeand an opposite first back edge, and the second shell member having asecond front edge and an opposite second back edge; a front zipperassembly joined to and selectively closing the respective first andsecond front edges as by a front first zipper strip affixed at the firstfront edge and a front second zipper strip affixed at the second frontedge; and a back zipper assembly joined to and selectively closing therespective first and second back edges as by a back first zipper stripaffixed at the first back edge and a back second zipper strip affixed atthe second back edge; whereby heat activation of the apparatus allowsfor conformable placement of the first and second shell members about abody part of a patient that is to be immobilized; whereby selectiveclosure of the front and back zipper assemblies joins the first andsecond shell members along the respective first and second front andback edges to install the apparatus about the body part of the patient;whereby cooling of the apparatus causes the first and second shellmembers to take a set conforming to the body part of the patient; andwhereby selective opening of one or both of the front and back zipperassemblies separates the first and second shell members along one orboth of the respective first and second front and back edges touninstall and allow removal of the apparatus from the body part of thepatient, at least a portion of one of the front and back zipperassemblies allowing for selective hinging of the set first and secondshell members for ease of removal and replacement of the apparatus inuse.

2. The apparatus of embodiment 1 having an upper end and an oppositelower end and wherein at least one of the front and back zipperassemblies extends distally beyond the first and second shell members atthe lower end of the apparatus.

3. The apparatus of embodiment 1 or embodiment 2 wherein a distal end ofthe back zipper assembly extends distally beyond the first and secondshell members at the lower end of the apparatus.

4. The apparatus of embodiment 3 wherein the back zipper assemblycomprises at least one zipper strip fastener member on an inner surfacethereof for selective engagement with a corresponding at least one shellfastener member.

5. The apparatus of embodiment 4 wherein a first shell fastener memberis formed on the front first zipper strip adjacent the first lower endof the first shell member and a second shell fastener member is formedon the front second zipper strip toward the second lower end of thesecond shell member, and wherein a back first zipper strip fastenermember is formed on the back first zipper strip distal of a first lowerend of the first shell member for selective engagement with the firstshell fastener member and a back second zipper strip fastener member isformed on the back second zipper strip distal of a second lower end ofthe second shell member for selective engagement with the second shellfastener member.

6. The apparatus of embodiment 4 or embodiment 5 wherein a toe box isincorporated into the distal end of the back zipper assembly, theselective engagement of the at least one zipper strip fastener memberwith the corresponding at least one shell fastener member serving toselectively secure the toe box in a curved and closed position over thelower end of the apparatus, and the selective disengagement of the atleast one zipper strip fastener member from the corresponding at leastone shell fastener member serving to selectively shift the toe box to anopen position pivoted away from the lower end of the apparatus, wherebyduring heat activation and forming the adjustability of the toe boxenables a single apparatus to accommodate a range of foot sizes.

7. The apparatus of embodiment 6 wherein the toe box is removablyengaged with the back zipper assembly.

8. The apparatus of embodiment 7 wherein an inner surface of the toe boxselectively engages the at least one zipper strip fastener member.

9. The apparatus of embodiment 8 wherein the toe box is formed having anouter surface configured to removably engage the back first and secondzipper strip fastener members to selectively secure the toe box on thedistal end of the back zipper assembly.

10. The apparatus of embodiment 6 wherein the toe box is integral withthe back zipper assembly.

11. The apparatus of embodiment 10 wherein the toe box comprises opposedfirst and second toe box members affixed to and extending laterally fromthe respective back first and second zipper strips.

12. The apparatus of embodiment 11 wherein a first reinforcing materialspanning from the first shell member to the first toe box member and asecond reinforcing material spanning from the second shell member to thesecond toe box member cooperate with the back zipper assembly tostabilize the toe box and enable the toe box to selectively pivotrelative to the lower end of the apparatus.

13. The apparatus of embodiment 11 or embodiment 12 wherein the backzipper assembly comprises at least one attachment material on an outersurface thereof for selective engagement with a non-slip material.

14. The apparatus of any of embodiments 11-13 wherein a first attachmentmaterial is applied along the back first zipper strip spanning the firsttoe box member and a first bottom portion of the first shell member anda second attachment material is applied along the back second zipperstrip spanning the second toe box member and a second bottom portion ofthe second shell member, and whereby the non-slip material is removablyengaged to both the first and second attachment materials so as to coverat least part of the back zipper assembly at the first and second bottomportions of the respective first and second shell members.

15. The apparatus of embodiment 14 wherein a first non-slip material isremovably engaged with the first attachment material and a secondnon-slip material is removably engaged with the second attachmentmaterial.

16. The apparatus of any of embodiments 6-15 wherein the toe box isformed with lateral protrusions to facilitate selective bending of thetoe box without bunching.

17. The apparatus of embodiment 16 wherein first protrusions extend fromthe first toe box member laterally away from the back first zipper stripand second protrusions extend from the second toe box member laterallyaway from the back second zipper strip.

18. The apparatus of any of embodiments 6-17 wherein the toe box is athermoformable material.

19. The apparatus of any of embodiments 1-18 further comprising apertureregions configured for providing increased stretchability during heatactivation and forming of the apparatus and increased breathabilityduring setting and use of the apparatus.

20. The apparatus of embodiment 19 further comprising a first loweraperture region and a second lower aperture region formed in therespective first and second shell members adjacent to the respectivefirst and second lower ends.

21. The apparatus of embodiment 20 further comprising a first upperaperture region and a second upper aperture region formed in therespective first and second shell members adjacent to respective firstand second upper ends opposite the first and second lower ends,apertures of the first and second upper aperture regions beingrelatively larger than apertures of the first and second lower apertureregions to accommodate larger size variation in forming the upper end ofthe apparatus.

22. The apparatus of embodiment 21 wherein the apertures of the firstand second upper aperture regions are diamond-shaped.

23. The apparatus of any of embodiments 19-22 further comprising a firstintermediate aperture region and a second intermediate aperture regionformed in the respective first and second shell members between theupper end and the lower end of the apparatus.

24. The apparatus of embodiment 23 wherein apertures of the first andsecond intermediate aperture regions are relatively smaller thanapertures of both the first and second upper aperture regions and thefirst and second lower aperture regions.

25. The apparatus of any of embodiments 1-24 wherein the front and backzipper assemblies contribute to lengthwise non-stretch zones in theapparatus even when heat activated and formable.

26. The apparatus of any of embodiments 1-25 wherein the first shellmember comprises a first substrate having a first coating and the secondshell member comprises a second substrate having a second coating.

27. The apparatus of embodiment 26 wherein the first and secondsubstrates are a thermoformable material.

28. The apparatus of embodiment 26 or embodiment 27 wherein the firstand second coatings are selected from the group consisting of siliconeand polyurethane.

29. The apparatus of any of embodiments 1-28 wherein the front zipperassembly comprises front top and bottom zipper pulls and the back zipperassembly comprises back top and bottom zipper pulls.

30. The apparatus of any of embodiments 1-29 wherein the back zipperassembly is approximately 20% longer than the first and second backedges.

31. The apparatus of embodiment 30 wherein the back zipper assembly isin the range of 15% to 25% longer than the first and second back edges.

32. The apparatus of any of embodiments 1-31 wherein the first andsecond shell members are symmetrical.

33. The apparatus of any of embodiments 1-32 further comprising aninsole having an upper surface and an opposite lower surface andselectively positionable within the apparatus between the first andsecond shell members such that the upper surface is facing toward theupper end of the apparatus.

34. The apparatus of embodiment 33 wherein the insole comprises multiplelayers.

35. The apparatus of embodiment 34 wherein at least one layer is athermoformable material.

36. The apparatus of embodiment 34 or embodiment 35 wherein at least onelayer is a closed cell foam.

37. The apparatus of embodiment 36 wherein the closed cell foam is atthe upper surface.

38. The apparatus of any of embodiments 34-37 comprising at least anupper layer, an intermediate layer adjacent to the upper layer, and alower layer adjacent to the intermediate layer.

39. The apparatus of embodiment 38 wherein the upper layer is a closedcell cross-linked polyethylene foam, the intermediate layer is amicrocellular polyurethane foam, and the lower layer is an ethylenevinyl acetate.

40. The apparatus of any of embodiments 33-39 wherein the insole iscompressible.

41. The apparatus of any of embodiments 33-40 wherein the insole furthercomprises a rocker extending away from the lower surface.

42. The apparatus of embodiment 41 wherein the rocker is integral withthe insole.

43. The apparatus of embodiment 41 wherein the rocker is removablyengageable with the insole.

44. The apparatus of any of embodiments 41-43 wherein the rockercomprises a rocker base and a rocker member.

45. The apparatus of embodiment 44 wherein the rocker base and therocker member are integral.

46. The apparatus of embodiment 44 or embodiment 45 wherein the rockerbase is removably engageable with the lower surface of the insole suchthat the rocker base is selectively repositionable relative to the lowersurface of the insole.

47. The apparatus of any of embodiments 44-46 wherein the rocker baseand the rocker member are removably engageable such that the rockermember is selectively repositionable relative to the rocker base.

48. The apparatus of any of embodiments 41-47 wherein the rocker forms acorresponding bottom rocker feature in the first and second shellmembers of the apparatus when heat activated and formed with the insoleand rocker therein.

49. The apparatus of any of embodiments 33-48 wherein the insole istrimmable.

50. The apparatus of embodiment 49 wherein trim lines are provided on atleast one of the upper and lower surfaces of the insole.

51. The apparatus of any of embodiments 1-50 further comprising at leastone of an inflation bladder and a cold therapy pad selectivelypositioned between the first and second shell members.

52. The apparatus of embodiment 51 wherein the inflation bladdercomprises an inflation bladder body and an inflation line in fluidcommunication with the inflation bladder body, the inflation linepassing through an aperture formed in the first or second shell members.

53. The apparatus of embodiment 51 wherein the cold therapy padcomprises a cold therapy pad body and an inlet line and an outlet lineboth in fluid communication with the cold therapy pad body, the inletand outlet lines passing through one or more apertures formed in thefirst or second shell members.

54. The apparatus of any of embodiments 1-53 further comprising at leastone strap about the first and second shell members to assist insecurement and fitment of the apparatus.

55. The apparatus of embodiment 54 wherein the at least one strapcomprises a compliance strap that must be destroyed to be removed.

56. A method of employing an orthosis apparatus as defined in any one ofembodiments 1-55, the method comprising the steps of: heating theapparatus to activate the thermoformable first and second shell members;applying the activated apparatus to a body part of a patient to beimmobilized as by positioning the malleable first and second shellmembers thereabout; closing the front and back zipper assemblies tosecure the apparatus on the body part of the patient; and forming thefirst and second shell members about the body part as the apparatuscools to set.

57. The method of embodiment 56 wherein the body part includes a footand the step of applying the activated apparatus further comprisespositioning an insole between the foot and the first and second shellmembers.

58. The method of embodiment 57 comprising the further step of havingthe back zipper assembly zipped at least from the distal end to the heelof the foot to facilitate placement of the insole.

59. The method of embodiment 57 or embodiment 58 comprising the furtherstep of selectively positioning a rocker on the lower surface of theinsole so as to form a corresponding bottom rocker feature in the firstand second shell members during the step of forming the first and secondshell members, the bottom rocker feature providing plantar pressureoffloading during use of the apparatus.

60. The method of any of embodiments 57-59 comprising the further stepof trimming the insole to an appropriate length based on the foot of thepatient.

61. The method of any of embodiments 57-60 comprising the further stepof forming a thermoformable toe box installed on the distal free end ofthe back zipper assembly of the apparatus as by bending and curving thetoe box comfortably about the toes of the foot of the patient.

62. The method of embodiment 61 comprising the further step of affixinga back zipper strip fastener member to a shell fastener member toremovably secure the toe box in the desired position.

63. The method of embodiment 61 or embodiment 62, further comprising thestep of hinging open the toe box to inspect the toes of the patientwithout removing the apparatus.

64. The method of any of embodiments 56-63, further comprising the stepof applying one or more retention or compliance straps about the firstand second shell members.

65. The method of any of embodiments 56-64, further comprising the stepof applying a non-slip material on the sole of the apparatus.

66. The method of embodiment 65 wherein the step of applying a non-slipmaterial comprises removably attaching the non-slip material toattachment material formed along at least a portion of the back zipperassembly.

67. The method of any of embodiments 56-66, further comprising the stepof unzipping at least one of the front and back zipper assemblies inwhole or in part to allow hinged movement between the first and secondshell members and selective removal and replacement of the apparatus.

68. A kit comprising an orthosis apparatus as defined in any one ofembodiments 1-55.

69. The kit of embodiment 68 comprising a first shell member, a secondshell member, and a toe box.

70. The kit of embodiment 68 or embodiment 69, further comprising aninsole.

71. The kit of embodiment 70 comprising a plurality of rockers.

72. The kit of any of embodiments 68-71, further comprising one or moreof a stockinette and a liner.

73. The kit of any of embodiments 68-72, further comprising one or morenon-slip strips.

74. The kit of any of embodiments 68-73, further comprising a pluralityof straps.

75. The kit of any of embodiments 68-74, further comprising one or moreof an inflation bladder and a cold therapy pad.

76. The kit of any of embodiments 68-75, further comprisinginstructional material.

77. The kit of embodiment 76, wherein the instructional materialprovides instructions on how to perform the method as defined in any oneof embodiments 56-67.

78. Use of an orthosis apparatus as defined in any one of embodiments1-55 to selectively immobilize a body part of a patient.

79. The use of embodiment 78, wherein the use comprises a method asdefined in any one of embodiments 56-67.

In closing, regarding the exemplary embodiments of the present inventionas shown and described herein, it will be appreciated that an improvedorthosis apparatus is disclosed and configured for being selectivelyformed and applied and removed. Because the principles of the inventionmay be practiced in a number of configurations beyond those shown anddescribed, it is to be understood that the invention is not in any waylimited by the exemplary embodiments, but is generally able to takenumerous forms without departing from the spirit and scope of theinvention. It will also be appreciated by those skilled in the art thatthe present invention is not limited to the particular geometries andmaterials of construction disclosed, but may instead entail otherfunctionally comparable structures or materials, now known or laterdeveloped, without departing from the spirit and scope of the invention.

Certain embodiments of the present invention are described herein,including the best mode known to the inventor(s) for carrying out theinvention. Of course, variations on these described embodiments willbecome apparent to those of ordinary skill in the art upon reading theforegoing description. The inventor(s) expect skilled artisans to employsuch variations as appropriate, and the inventor(s) intend for thepresent invention to be practiced otherwise than specifically describedherein. Accordingly, this invention includes all modifications andequivalents of the subject matter recited in the claims appended heretoas permitted by applicable law. Moreover, any combination of theabove-described embodiments in all possible variations thereof isencompassed by the invention unless otherwise indicated herein orotherwise clearly contradicted by context.

Groupings of alternative embodiments, elements, or steps of the presentinvention are not to be construed as limitations. Each group member maybe referred to and claimed individually or in any combination with othergroup members disclosed herein. It is anticipated that one or moremembers of a group may be included in, or deleted from, a group forreasons of convenience and/or patentability. When any such inclusion ordeletion occurs, the specification is deemed to contain the group asmodified thus fulfilling the written description of all Markush groupsused in the appended claims.

In some embodiments, the numbers expressing quantities of ingredients,properties such as concentration, reaction conditions, and so forth,used to describe and claim certain embodiments of the inventive subjectmatter are to be understood as being modified in some instances by theterms “about” or “approximately.” Accordingly, in some embodiments, thenumerical parameters set forth in the written description and attachedclaims are approximations that can vary depending upon the desiredproperties sought to be obtained by a particular embodiment. In someembodiments, the numerical parameters should be construed in light ofthe number of reported significant digits and by applying ordinaryrounding techniques. Notwithstanding that the numerical ranges andparameters setting forth the broad scope of some embodiments of theinventive subject matter are approximations, the numerical values setforth in the specific examples are reported as precisely as practicable.The numerical values presented in some embodiments of the inventivesubject matter may contain certain errors necessarily resulting from thestandard deviation found in their respective testing measurements.

Unless the context dictates the contrary, all ranges set forth hereinshould be interpreted as being inclusive of their endpoints andopen-ended ranges should be interpreted to include only commerciallypractical values. The recitation of numerical ranges of values herein ismerely intended to serve as a shorthand method of referring individuallyto each separate value falling within the range. Unless otherwiseindicated herein, each individual value of a numerical range isincorporated into the specification as if it were individually recitedherein. Similarly, all lists of values should be considered as inclusiveof intermediate values unless the context indicates the contrary.

Use of the terms “may” or “can” in reference to an embodiment or aspectof an embodiment also carries with it the alternative meaning of “maynot” or “cannot.” As such, if the present specification discloses thatan embodiment or an aspect of an embodiment may be or can be included aspart of the inventive subject matter, then the negative limitation orexclusionary proviso is also explicitly meant, meaning that anembodiment or an aspect of an embodiment may not be or cannot beincluded as part of the inventive subject matter. In a similar manner,use of the term “optionally” in reference to an embodiment or aspect ofan embodiment means that such embodiment or aspect of the embodiment maybe included as part of the inventive subject matter or may not beincluded as part of the inventive subject matter. Whether such anegative limitation or exclusionary proviso applies will be based onwhether the negative limitation or exclusionary proviso is recited inthe claimed subject matter.

The terms “a,” “an,” “the” and similar references used in the context ofdescribing the present invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. Further, ordinal indicators—such as “first,” “second,” “third,”etc.—for identified elements are used to distinguish between theelements, and do not indicate or imply a required or limited number ofsuch elements, and do not indicate a particular position or order ofsuch elements unless otherwise specifically stated.

All methods described herein can be performed in any suitable orderunless otherwise indicated herein or otherwise clearly contradicted bycontext. The use of any and all examples, or exemplary language (e.g.,“such as”) provided with respect to certain embodiments herein isintended merely to better illuminate the inventive subject matter anddoes not pose a limitation on the scope of the inventive subject matterotherwise claimed. No language in the application should be construed asindicating any non-claimed element essential to the practice of theinvention.

It should be apparent to those skilled in the art that many moremodifications besides those already described are possible withoutdeparting from the inventive concepts herein. The inventive subjectmatter, therefore, is not to be restricted except in the spirit of theappended claims. Moreover, in interpreting both the specification andthe claims, all terms should be interpreted in the broadest possiblemanner consistent with the context. In particular, the terms “comprises”and “comprising” should be interpreted as referring to elements,components, or steps in a non-exclusive manner, indicating that thereferenced elements, components, or steps may be present, or utilized,or combined with other elements, components, or steps that are notexpressly referenced. Where the specification claims refers to at leastone of something selected from the group consisting of A, B, C and N,the text should be interpreted as requiring only one element from thegroup, not A plus N, or B plus N, etc.

While aspects of the invention have been described with reference to atleast one exemplary embodiment, it is to be clearly understood by thoseskilled in the art that the invention is not limited thereto. Rather,the scope of the invention is to be interpreted only in conjunction withany appended claims here or in any patent application claiming thebenefit hereof, and it is made clear that the inventor(s) believe thatthe claimed subject matter is the invention.

What is claimed is:
 1. A thermoformable orthosis apparatus comprising: athermoformable first shell member and an opposed thermoformable secondshell member, the first shell member having a first front edge and anopposite first back edge, and the second shell member having a secondfront edge and an opposite second back edge; a front zipper assemblyjoined to and selectively closing the respective first and second frontedges as by a front first zipper strip affixed at the first front edgeand a front second zipper strip affixed at the second front edge; and aback zipper assembly joined to and selectively closing the respectivefirst and second back edges as by a back first zipper strip affixed atthe first back edge and a back second zipper strip affixed at the secondback edge; whereby heat activation of the apparatus allows forconformable placement of the first and second shell members about a bodypart of a patient that is to be immobilized; whereby selective closureof the front and back zipper assemblies joins the first and second shellmembers along the respective first and second front and back edges toinstall the apparatus about the body part of the patient; wherebycooling of the apparatus causes the first and second shell members toset conforming to the body part of the patient; and whereby selectiveopening of one or both of the front and back zipper assemblies separatesthe first and second shell members along one or both of the respectivefirst and second front and back edges to uninstall and allow removal ofthe apparatus from the body part of the patient, at least a portion ofone of the front and back zipper assemblies allowing for selectivehinging of the set first and second shell members for ease of removaland replacement of the apparatus in use; and further wherein: the backfirst and second zipper strips at a distal end of the back zipperassembly extend distally beyond the respective first and second shellmembers at a lower end of the apparatus; the back zipper assemblycomprises at least one zipper strip fastener member on an inner surfacethereof for selective engagement with a corresponding at least one shellfastener member; and a toe box is incorporated into the distal end ofthe back zipper assembly, the selective engagement of the at least onezipper strip fastener member with the corresponding at least one shellfastener member serving to selectively secure the toe box in a curvedand closed position over the lower end of the apparatus, and theselective disengagement of the at least one zipper strip fastener memberfrom the corresponding at least one shell fastener member serving toselectively shift the toe box to an open position pivoted away from thelower end of the apparatus, whereby during heat activation and formingthe adjustability of the toe box enables a single apparatus toaccommodate a range of foot sizes.
 2. The apparatus of claim 1 whereinthe toe box is removably engaged with the back zipper assembly.
 3. Theapparatus of claim 1 wherein the toe box is integral with the backzipper assembly.
 4. The apparatus of claim 3 wherein the toe boxcomprises opposed first and second toe box members affixed to andextending laterally from the respective back first and second zipperstrips of the back zipper assembly.
 5. The apparatus of claim 4 whereina first reinforcing material spanning from the first shell member to thefirst toe box member and a second reinforcing material spanning from thesecond shell member to the second toe box member cooperate with the backzipper assembly to stabilize the toe box and enable the toe box toselectively pivot relative to the lower end of the apparatus.
 6. Theapparatus of claim 1 wherein the toe box is formed with lateralprotrusions to facilitate selective bending of the toe box withoutbunching.
 7. The apparatus of claim 1 wherein the toe box is athermoformable material.
 8. The apparatus of claim 1 wherein the frontfirst and second zipper strips and the back first and second zipperstrips are formed of a non-elastic material, whereby the respectivefirst and second front edges and first and second back edges of thefirst and second shell members are reinforced and rendered non-elasticso as to form lengthwise non-stretch zones in the apparatus.
 9. Theapparatus of claim 1 wherein the back zipper assembly comprises at leastone attachment material on an outer surface thereof for selectiveengagement with a non-slip material.
 10. The apparatus of claim 1further comprising aperture regions configured for providing increasedstretchability during heat activation and forming of the apparatus andincreased breathability during setting and use of the apparatus, whereinthe front and back zipper assemblies contribute to lengthwisenon-stretch zones in the apparatus even when heat activated and formableto maintain the overall integrity of the apparatus.
 11. The apparatus ofclaim 10 further comprising a first upper aperture region and a secondupper aperture region formed in the respective first and second shellmembers adjacent to respective first and second upper ends oppositerespective first and second lower ends of the respective first andsecond shell members, apertures of the first and second upper apertureregions being relatively larger than apertures of the first and secondlower aperture regions formed in the respective first and second shellmembers adjacent to the respective first and second lower ends toaccommodate larger size variation in forming the first and second upperends of the respective first and second shell members of the apparatus.12. The apparatus of claim 1 further comprising an insole having anupper surface and an opposite lower surface and being selectivelypositionable within the apparatus between the first and second shellmembers such that the upper surface is facing toward an upper end of theapparatus, the insole comprising multiple layers.
 13. The apparatus ofclaim 12 wherein at least one layer of the insole is a thermoformablematerial.
 14. The apparatus of claim 12 wherein the insole comprises atleast an upper layer, an intermediate layer adjacent to the upper layer,and a lower layer adjacent to the intermediate layer, wherein the upperlayer is a closed cell cross-linked polyethylene foam, the intermediatelayer is a microcellular polyurethane foam, and the lower layer isethylene vinyl acetate.
 15. The apparatus of claim 12 wherein the insolefurther comprises a selectively repositionable rocker extending awayfrom the lower surface, the rocker configured to form a correspondingbottom rocker feature in the first and second shells of the apparatuswhen heat activated and formable.
 16. A thermoformable orthosisapparatus comprising: a thermoformable first shell member and an opposedthermoformable second shell member, the first shell member having afirst front edge and an opposite first back edge, and the second shellmember having a second front edge and an opposite second back edge; afront zipper assembly joined to and selectively closing the respectivefirst and second front edges as by a front first zipper strip affixed atthe first front edge and a front second zipper strip affixed at thesecond front edge; a back zipper assembly joined to and selectivelyclosing the respective first and second back edges as by a back firstzipper strip affixed at the first back edge and a back second zipperstrip affixed at the second back edge, a distal end of the back zipperassembly extending distally beyond the first and second shell members ata lower end of the apparatus; and a thermoformable toe box formedintegrally with the distal end of the back zipper assembly, the toe boxcomprising opposed first and second toe box members affixed to andextending laterally from the respective back first and second zipperstrips of the back zipper assembly and terminating laterally inspaced-apart protrusions; whereby heat activation of the apparatusallows for conformable placement of the first and second shell membersand the toe box about a body part of a patient that is to beimmobilized; whereby selective closure of the front and back zipperassemblies joins the first and second shell members along the respectivefirst and second front and back edges to install the apparatus about thebody part of the patient and selective pivoting of the toe box about thelower end of the apparatus positions the toe box in a curvedconfiguration over the lower end, during heat activation and forming theadjustability of the toe box enabling a single apparatus to accommodatea range of foot sizes; whereby cooling of the apparatus causes the firstand second shell members and the toe box to set conforming to the bodypart of the patient; whereby selective pivoting of the toe box opens thelower end of the apparatus; and whereby selective opening of one or bothof the front and back zipper assemblies separates the first and secondshell members along one or both of the respective first and second frontand back edges to uninstall and allow removal of the apparatus from thebody part of the patient, at least a portion of one of the front andback zipper assemblies allowing for selective hinging of the set firstand second shell members for ease of removal and replacement of theapparatus in use.